Journal of Cosmetic Dermatology

ORIGINAL ARTICLE OPEN ACCESS

Efficacy and Tolerability of a Novel Cosmetic and

Over-­the-­Counter Facial Acne Regimen Versus a
Prescription Treatment
Priscilla Huang1 | Olivia Supan1 | Cecilia L. Pak 2 | Rahul C. Mehta1 | Elizabeth T. Makino1

1 Allergan Aesthetics, an AbbVie Company, Irvine, California, USA | 2SGS Stephens Inc., Richardson, Texas, USA

Correspondence: Olivia Supan ([email protected])

Received: 24 June 2024 | Revised: 21 August 2024 | Accepted: 26 August 2024

Funding: Allergan Aesthetics, an AbbVie Company, funded this study and participated in the study design, research, analysis, data collection, interpreta-
tion of data, reviewing, and approval of the publication. All authors had access to relevant data and participated in the drafting, review, and approval of this
publication. No honoraria or payments were made for authorship. Medical writing support was provided by Illyce Nuñez, PhD of Peloton Advantage, LLC,
an OPEN Health company, and funded by Allergan Aesthetics, an AbbVie Company.

Keywords: acne vulgaris | erythema | post-­inflammatory hyperpigmentation | salicylic acid

ABSTRACT
Background: The SkinMedica Acne Treatment Platform (SM Regimen) was formulated to treat acne without overdrying the
skin. We evaluated efficacy and tolerability of the SM Regimen (including a novel 1% salicylic acid Acne Clarifying Cleanser
and 2% salicylic acid Acne Treatment Lotion) versus a prescription formulation (Rx Regimen; including adapalene 0.1%/benzoyl
peroxide 2.5%) in a diverse population of adults with mild to moderate facial acne.
Methods: This single-­center, double-­blind, randomized study enrolled adults (18–45 years) with Fitzpatrick skin types (FST)
I–VI. SM Regimen or Rx Regimen was applied topically to the entire face for 12 weeks. Assessments were conducted at 24 and
48 h and 4, 8, and 12 weeks.
Results: Subjects (SM Regimen, n = 31; Rx Regimen, n = 23) were primarily female (90.7%) with mean age of 28.6 years; 53.8%
had FST IV–VI. Efficacy was comparable between regimens. The SM regimen resulted in significant improvements versus base-
line in mean Investigator's Global Assessment of acne severity from 48 h through week 12 (p ≤ 0.001), as well as significant and
sustained improvements from baseline in total acne lesion count, global postinflammatory hyperpigmentation/postinflamma-
tory erythema, and oiliness. The SM Regimen was well tolerated at all time points, with mean scores below mild for all parame-
ters; the Rx Regimen caused significantly more tightness/dry feeling at week 4 versus SM Regimen (p = 0.008). Subjects (> 96%)
reported high satisfaction with the SM Regimen at all time points.
Conclusions: The SM Regimen reduced acne severity and skin oiliness, evening out skin tone without overdrying or irritating
the skin.

Rahul C. Mehta is a former employee of Allergan Aesthetics, an AbbVie Company.

This is an open access article under the terms of the Creative Commons Attribution License, which permits use, distribution and reproduction in any medium, provided the original work is
properly cited.

© 2024 The Author(s). Journal of Cosmetic Dermatology published by Wiley Periodicals LLC.

Journal of Cosmetic Dermatology, 2024; 0:1–10 1 of 10

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1   |   Introduction the SM Regimen may help address this mechanism of acne
pathogenesis.
Acne vulgaris development is multifactorial, resulting in
part from blocked follicles, keratinocyte hyperproliferation, This study evaluated the efficacy and tolerability of the SM
increased sebum production and excretion, the presence of Regimen compared with a topical prescription formulation
Cutibacterium acnes within the follicle, and inflammatory (adapalene 0.1%/BP 2.5%; Rx Regimen) over 12 weeks in a diverse
mediators released from nearby skin cells [1, 2]. Acne lesions population of adults with acne, including those with PIH/PIE.
and other sequelae, including postinflammatory erythema
(PIE), postinflammatory hyperpigmentation (PIH), and scar-
ring, can negatively affect psychosocial well-­being and quality 2   |   Materials and Methods
of life [3–6].
2.1   |   Study Design
Adult acne, occurring after 25 years of age, typically presents as
mild to moderate facial inflammatory papulopustular lesions This single-­center, double-­blind, randomized clinical study was
[7], and has a higher prevalence in women (12%) versus men conducted from June 13, 2022 to March 22, 2023. Healthy males
(3%) [8]. Inflammatory lesions may result from chronic stimula- and females, 18–45 years of age with FST I–VI, who had mild to
tion of the innate immune system by resistant strains of C. acnes moderate severity of facial acne (scores of 2–3 on the US Food and
[3]. PIH and scarring are frequent among women [8] and can be Drug Administration [FDA] Investigator's Global Assessment
more prevalent and prominent in adults with Fitzpatrick skin [IGA] of acne scale; 0 = clear skin, 4 = severe) were enrolled. Eligible
types (FST) IV, V, and VI who may require long-­term therapy subjects had ≥ 2 inflammatory lesions and 10–100 noninflamma-
for control [9, 10]. tory lesions on the face, ≥ 1 isolated inflammatory lesion for target
grading, and no facial treatments in the past 6 months, and were
Current treatments for mild to moderate acne include topical willing to withhold all facial treatments for improving the appear-
formulations containing benzoyl peroxide (BP; antimicrobial), ance or firmness of facial skin throughout the study. The target
adapalene (retinoid), salicylic acid and azelaic acid (kerato- enrollment was 65 subjects, with at least 50 subjects expected to
lytic), sulfur (keratolytic and bacteriostatic), and antibiotics complete the trial (30 subjects in the SM Regimen group and 20
[11]. Salicylic acid, found in both over-­the-­counter and prescrip- subjects in the Rx Regimen group). In the SM Regimen group, ≥ 15
tion topical agents, is effective against inflammatory and subjects were required to have FST I–III, with the remainder hav-
noninflammatory acne lesions. Some local skin irritation is pos- ing FST IV–VI, and ≥ 15 subjects had to have mild PIH/PIE acne
sible at higher, prescription doses of salicylic acid (> 2%) [2, 12]. marks (score ≥ 1 according to a modified Griffith's 10-­point scale
Adapalene 0.1% combined with BP 2.5% (Epiduo; Galderma, [0 = none, 9 = severe]). In the Rx Regimen group, ≥ 10 subjects were
Lausanne, Switzerland), a widely used, prescription topical required to have FST I–III, with the remainder having FST IV–VI,
combination, has demonstrated efficacy for the treatment of and ≥ 10 subjects had to have mild PIH/PIE acne marks.
moderate to severe acne [13]. Although adapalene 0.1%/BP 2.5%
was well tolerated in clinical studies, potential adverse events of Key exclusion criteria were history of skin cancer within the past
dryness and scaling may limit its use, particularly for individu- 5 years or current or prior use of the oral or topical treatments
als with dry, sensitive, or aging skin [11, 14]. There is an unmet (e.g., oral isotretinoin within 6 months, oral or topical prescrip-
need for treatments suitable for mild to moderate acne in all skin tion medications for acne within 30 days, any systemic medica-
types and gentle enough for adults with aging skin, who may tion considered to affect the course of acne within 30 days [e.g.,
require extended treatment. antibiotics, steroids]; over-­the-­counter retinol-­containing topical
or systemic products within 30 days; and other topical over-­the-­
The SkinMedica Acne Treatment Platform is a topical com- counter products within 14 days).
bination regimen consisting of a cosmetic Acne Clarifying
Cleanser and over-­the-­counter Acne Treatment Lotion (SM Subjects were randomized to receive the SM Regimen, consist-
Regimen) that acts multimodally to target pathways contrib- ing of Acne Clarifying Cleanser (salicylic acid 1%) and Acne
uting to acne formation. The Acne Clarifying Cleanser is a Treatment Lotion (salicylic acid 2%), or the Rx Regimen, con-
blend of 1% salicylic acid with bakuchiol (antioxidant, anti-­ sisting of adapalene 0.1% and BP 2.5%. In the SM Regimen
inflammatory, antibacterial), bisabolol (anti-­ inflammatory), group, subjects applied the Acne Clarifying Cleanser and Acne
aloe and olive leaf (soothing), and licorice root extract (an- Treatment Lotion on the full face twice daily (AM/PM). In the
tioxidant). The Acne Treatment Lotion contains a blend of Rx Regimen group, subjects applied adapalene 0.1% and BP 2.5%
encapsulated 2% salicylic acid and bakuchiol, niacinamide once daily at night, in accordance with the prescribing informa-
(antioxidant, anti-­inflammatory), and Centella asiatica extract tion. Both groups used SkinMedica Facial Cleanser (AM/PM),
(anti-­inflammatory, antioxidant) for exfoliating acne-­causing SkinMedica Ultra Sheer Moisturizer (AM/PM), and SkinMedica
dead skin, oil, and dirt without overdrying and irritating the Essential Defense Mineral Shield SPF 35 (AM only). Study visits
skin; and a synergistic complex of manuka, black cumin, occurred at baseline, 24 and 48 h, and 4, 8, and 12 weeks.
magnolia, and chaulmoogra for sebum control, prevention of
sebum oxidation, and antimicrobial effects [15–18]. The ox- The study was approved by an institutional review board (Advarra
idation of lipid components of sebum, such as squalene, can IRB, Columbia, MD, USA) and conducted in accordance with all
stimulate keratinocyte proliferation and the release of in- applicable guidelines for the protection of human subjects for re-
flammatory mediators [19]. By modulating sebum oxidation, search as required by 21 Code of Federal Regulations (CFR) 50.25

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and the accepted standards for Good Clinical Practice. All sub- 2.2.4   |   PIH/PIE Assessments
jects provided written informed consent before study enrollment.
Global PIH/PIE assessment of the entire face was evaluated
at each visit using 10-­point modified Griffith's scale as none
2.2   |   Endpoints and Assessments (score of 0), mild (1–3), moderate (4–6), and severe (7–9). Target
PIH/PIE lesions (1 or 2) were graded at baseline and 4, 8, and
2.2.1   |   FDA IGA of Acne Severity 12 weeks for darkness (score of 0 [equal to tone/color of sur-
rounding skin, no visible PIH/PIE] to 6 [extremely darker/red-
Investigators assessed global acne severity at each visit on a 5-­ der than surrounding skin]) and size (score of 0 [not visible]; 1
point scale as clear skin (grade 0), almost clear (grade 1), mild [≤ 1-­mm diameter]; 2 [> 1-­to 2-­mm diameter]; 3 [> 2-­to 3-­mm
(grade 2), moderate (grade 3), and severe (grade 4). diameter]; 4 [> 3-­mm diameter]).

2.2.2   |   Acne Lesion Counts 2.2.5   |   Tactile Oiliness

Investigator-­assessed counts of total acne lesions, inflammatory Investigator-­assessed clinical grading of tactile oiliness was per-
lesions (papules, pustules), and noninflammatory lesions (open formed at each visit using the following scale: 0 (no oily feel); 1–3
and closed comedones) on the face were recorded at each visit. (mild oily feel); 4–6 (moderate oily feel); and 7–9 (strong oily feel).
Lesion counts were assessed separately for the forehead, left and
right cheeks (including the side of nose), and chin (including the
area above the upper lip). 2.2.6   |   Subject Self-­Assessment

Subjects completed a sponsor-­provided self-­assessment ques-

2.2.3   |   Target Inflammatory Lesion Assessment tionnaire at 24 and 48 h and 4, 8, and 12 weeks to record their
experience and level of satisfaction with the test products.
Target lesions were papules or pustules emerging within 48 h
of baseline and between 0.1 and 0.5 cm in size. Investigator-­
assessed clinical grading of 1 or 2 target lesions was performed 2.2.7   |   Imaging Procedures
at baseline and at 24 and 48 h. Lesions were graded for redness
(score of 0 [none] to 4 [severe]), elevation (score of 0 [completely VISIA-­CR imaging was performed at each visit. Subjects were
flat] to 4 [severely raised/very “swollen”]), and size/diameter photographed using the VISIA-­ CR photo-­ station (Canfield
(score of 0 [not visible]; 1 [≤ 1-­mm diameter]; 2 [> 1-­to 2-­mm Imaging Systems, Fairfield, NJ, USA) with a Canon Mark digital
diameter]; 3 [> 2-­to 3-­mm diameter]; 4 [> 3-­mm diameter]). SLR camera (Canon Inc., Tokyo, Japan).

TABLE 1    |    Subject demographics and baseline characteristics.

SM Regimen (n = 31) Rx Regimen (n = 23) Total (N = 54)

Age, mean (SD) years 28.8 (7.7) 28.3 (6.6) 28.6 (7.2)
Gender, n (%)
Female 27 (87.1) 22 (95.7) 49 (90.7)
Male 4 (12.9) 1 (4.3) 5 (9.3)
Ethnicity, n (%)
Hispanic or Latino 1 (3.2) 3 (13.0) 4 (7.4)
Not Hispanic or Latino 30 (96.8) 20 (87.0) 50 (92.6)
Race, n (%)
Asian 8 (25.8) 1 (4.3) 9 (16.7)
Black/African American 13 (41.9) 11 (47.8) 24 (44.4)
White/Caucasian 10 (32.3) 11 (47.8) 21 (38.9)
Fitzpatrick skin type, n (%)
I–III 14 (45.2) 11 (47.8) 25 (46.3)
IV–VI 17 (54.8) 12 (52.2) 29 (53.7)

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FIGURE 1    |    Change from baseline in mean IGA acne severity assessment over time. No statistical significance was observed between treatment
groups. IGA, Investigator's Global Assessment. *p ≤ 0.004 versus baseline.

FIGURE 2    |    Percent change from baseline in mean total acne lesion count over time. *p < 0.001 versus baseline. †p = 0.021 versus Rx Regimen.

2.2.8   |   Tolerability Assessments baseline were analyzed by Wilcoxon signed rank test. Statistical
tests were 2-­sided (α = 0.05) and performed using SAS software
Tolerability evaluations were performed at each visit. version 9.4 (SAS Statistical Institute).
Investigator-­assessed erythema and dryness/scaling were as-
sessed on a 10-­point scale (0 = none, 1–3 = mild, 4–6 = moderate,
7–9 = severe) and edema on a 4-­point scale (0 = none, 1 = mild, 3   |   Results
2 = moderate, and 3 = severe). Subject assessments of burning,
itching, and tightness/dry feeling were reported on a 4-­point 3.1   |   Subjects
scale (0 = none, 1 = mild, 2 = moderate, and 3 = severe).
A total of 63 subjects were enrolled and 54 subjects were
included in the ITT population (SM Regimen, n = 31; Rx
2.3   |   Statistical Methods Regimen, n = 23; Table 1). Most subjects were female (90.7%),
and there was a balanced proportion of subjects with FST IV–
Target enrollment was based on the number of patients typically VI (> 50% in both groups). In the SM Regimen versus the Rx
enrolled in past studies investigating topical skincare products. Regimen group, respectively, there were numerically lower
Analyses were conducted in the intent-­to-­treat (ITT) population, proportions of White subjects (32.3% vs. 47.8%) and Black or
which included all treated subjects with at least 1 post-­baseline African American subjects (41.9% vs. 47.8%) and a higher pro-
evaluation. Between-­ group comparisons and change from portion of Asian subjects (25.8% vs. 4.3%). A total of 14 subjects

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discontinued the study (SM Regimen, n = 9; Rx Regimen,

Week 12

−46.4%*
−68.3%*
n = 5) due to subject-­
requested withdrawal (SM Regimen,

−47.2%*
−55.1%*
—
—
—
n = 3; Rx Regimen, n = 2), lost to follow-­up (SM Regimen,
n = 5; Rx Regimen, n = 2), did not meet protocol criteria (SM
Regimen, n = 1; Rx Regimen, n = 0), and noncompliance (SM
Regimen, n = 0; Rx Regimen, n = 1).

−62.8%*
−41.2%*

−31.4%*
−37.6%*
Week 8

—
—
—
3.2   |   Efficacy
Rx Regimen

3.2.1   |   IGA of Acne Severity

−39.2%*,§
−52.2%*

−26.8%*
−20.8%†
Week 4

—
—
—
For both treatment groups, significant improvements versus
baseline were observed in mean global acne severity scores at

Note: Indicates statistically significant improvement versus baseline: *p < 0.001; †p < 0.005; ‡p < 0.05. Indicates statistically significant improvement versus the other group: §p < 0.05.
each follow-­up visit from 48 h through 12 weeks (p ≤ 0.004;
Figure 1). No statistically significant differences in mean scores
−40.4%*
−32.7%*

−15.3%‡
−28.6%†
−31.1%*
48 h

between treatments were observed.

—
— 3.2.2   |   Acne Lesion Counts
−13.5%†
−15.7%†
−10.2%
−5.0%

−1.7%
24 h

—
—

Significant improvements in total acne lesion counts versus

baseline were observed at 24 h for the SM Regimen and at 48 h
for the Rx Regimen, with significant improvements at all sub-
Week 12

sequent time points (p ≤ 0.001; Figure 2). No significant differ-

−66.6%*
−45.4%*

−56.2%*
−57.9%*

ences between treatments were observed except at 24 h, when

—

—
—

the SM Regimen showed greater improvement from baseline

versus the Rx Regimen (p = 0.021).
−40.2%*
−46.1%*
−55.4%*
Week 8

−37.9%†

The SM Regimen showed significant improvement in non-

—

—
—

inflammatory lesion count compared both with baseline

(p < 0.001) and with the Rx Regimen (p = 0.016) at 24 h (Table 2).
Significant improvements from baseline were observed for both
SM Regimen

the SM Regimen and Rx Regimen from 48 h up to 12 weeks

−42.8%*

−25.2%*
−25.2%*
Week 4

−21.6%

(p < 0.001).
—

—
—

Compared with baseline, significant improvements in mean

TABLE 2    |    Mean percentage change from baseline in investigator assessments.

Abbreviation: PIH/PIE, postinflammatory hyperpigmentation/postinflammatory erythema.

inflammatory lesion count were observed starting at 8 weeks

for the SM Regimen (p = 0.003) and at 48 h for the Rx Regimen
−45.6%*
−37.0%*

−37.3%*

−18.3%†
−15.3%
48 h

(p = 0.005), with significant improvement versus baseline in

—
—

both groups up to 12 weeks (Table 2). No statistically signifi-

cant differences in mean inflammatory lesion count between
treatments were observed, except at 4 weeks, when change from
baseline was significantly greater for the Rx Regimen versus the
−15.3%*,§

−20.7%*
−16.9%*
−3.0%

−2.7%
24 h

SM Regimen (p = 0.036).
—
—

3.2.3   |   Target Inflammatory Lesion Assessments

Target inflammatory lesion assessment

Compared with baseline, both regimens showed significant re-

Mean percentage change from

ductions in redness and elevation of target inflammatory lesions

Target PIH/PIE lesion grading

at 24 and 48 h (p ≤ 0.004) and in size at 48 h (p ≤ 0.008) (Table 2).

No statistically significant differences in target inflammatory
lesions between groups were observed.
Noninflammatory
Acne lesion count

Size/Diameter
Inflammatory

3.2.4   |   PIH/PIE Assessments
Elevation

Darkness
Redness
baseline

Statistically significant improvements versus baseline in

Size

global PIH/PIE assessment scores were observed with the SM

Regimen starting at 48 h and with the Rx Regimen starting at

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FIGURE 3    |    Percentage change from baseline in mean assessment of global PIH/PIE. No statistical significance was observed between treatment
groups. PIH/PIE, postinflammatory hyperpigmentation/postinflammatory erythema. *p ≤ 0.004 versus baseline.

FIGURE 4    |    Percentage change from baseline in investigator grading of mean tactile oiliness (forehead) over time. No statistical significance was
observed between treatment groups. *p ≤ 0.004 versus baseline; †p = 0.047 versus baseline.

4 weeks, with significant improvements observed up to 12 weeks 48 h only (p = 0.047; Figure 4). There was no statistically signifi-
(p ≤ 0.004) (Figure 3). The size and darkness of the target PIH/ cant difference in tactile oiliness between groups.
PIE lesions were significantly improved versus baseline at 4, 8,
and 12 weeks with both regimens (p ≤ 0.002; Table 2). No statis-
tically significant differences were observed between groups in 3.3   |   Subject Self-­Assessment Questionnaire
global or target PIH/PIE lesion scores.
Subjects consistently rated the SM Regimen highly across sev-
eral parameters at 24 and 48 h and at 12 weeks. The highest-­
3.2.5   |   Tactile Oiliness rated parameters included statements about not drying out the
skin (≥ 95% of subjects agreed at 24 h), made my skin look and
The SM Regimen significantly reduced tactile oiliness at all feel less oily (93% at 4 weeks), and made my skin look clearer
timepoints compared with baseline (p ≤ 0.004), whereas the Rx (90% and 93% of subjects agreed at 48 h and 4 weeks, respec-
Regimen showed significant improvements versus baseline at tively). Subjects reported favorable treatment satisfaction at all

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3.5   |   Safety and Tolerability

Treatment-­related adverse events were reported in three sub-

jects. One subject in the SM Regimen group experienced a rash
on the face that was moderate in severity and possibly treatment
related. In the Rx group, one subject developed moderate skin
exfoliation and burning sensation on the face, and one subject
experienced moderate skin exfoliation and mild pruritus in the
upper eyelids and mouth. All events were resolved.

Both treatment regimens were well tolerated at all time points,

with mean scores remaining below mild for all tolerability pa-
rameters and no significant increases from baseline through-
out the study. However, subjects consistently experienced
worsened tightness/dry feeling in the Rx Regimen group at
follow-­up visits, whereas the SM Regimen group experienced
a decrease in tightness/dry feeling. At week 4, subjects in
the Rx Regimen experienced significantly worse tightness/
dry feeling compared with the SM Regimen group (p = 0.008;
Figure 6).

4   |   Discussion

Acne can have a substantial aesthetic impact, creating a psycho-

social burden on affected individuals regardless of acne severity.
The impact of acne on quality of life is greater in individuals
who are female, older, or have a longer acne duration (> 5 years)
[20], and persons with acne have reported social, psychological,
and emotional burdens similar to or greater than those reported
by patients with chronic asthma, epilepsy, diabetes, back pain,
and arthritis [6]. Adults with greater skin-­related anxiety have
also reported a lower intention to participate in sports and ex-
ercise, experienced lower self-­esteem, and had worse quality of
life [21]. Despite the availability of effective nonprescription and
prescription-­grade treatments for mild to moderate adult acne,
topical treatments are often limited by tolerability issues, includ-
ing dryness, peeling, and skin irritation [11]. These issues, re-
lated to disruption of the stratum corneum permeability barrier,
can result in increased skin sensitivity [22]. Thus, patients may
continue to experience distress even if acne has improved with
treatment. Considering these issues, there is a need for effective
FIGURE 5    |    Representative images at baseline and after treatment
treatments that are gentle on the skin and address tolerability
with SM Regimen. (a) Black/African American female, aged 40 years
concerns.
with FST V, showing a reduction in acne lesions and skin oiliness. (b)
Black/African American female, aged 28 years with FST VI, showing
In this randomized, double-­blind study of adults with acne, in-
reduced skin oiliness and more even skin tone. (c) White/Caucasian
cluding subjects with PIH/PIE, the SM Regimen (1% salicylic
male, aged 31 years with FST III, showing rapid reduction in size of
acid cosmetic Acne Clarifying Cleanser and 2% salicylic acid
inflammatory acne lesions on the forehead. FST, Fitzpatrick skin type.
over-­the-­counter Acne Treatment Lotion) was well tolerated and
nondrying, and demonstrated significant improvements from
time points for the SM Regimen (100% satisfaction at 24 and 48 h baseline in acne severity assessments, PIH/PIE, and tactile oil-
and at 4 and 8 weeks, and 96.4% at 12 weeks). iness. When compared with a popular Rx Regimen (adapalene
0.1% and BP 2.5%), the SM Regimen showed comparable over-
all efficacy. However, reductions in total acne lesion counts
3.4   |   Photographic Evidence and noninflammatory lesion counts at 24 h were significantly
greater with the SM regimen. The SM Regimen also resulted in
Representative photographs of improvements from baseline significant improvements from baseline in tactile oiliness at all
in the appearance of acne and PIH/PIE lesions with the SM time points, whereas the Rx Regimen significantly improved
Regimen are presented in Figure 5. tactile oiliness only at 48 h.

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FIGURE 6    |    Change from baseline in mean tolerability assessments of tightness and dry feeling over time. No statistical significance compared
with baseline at any time point. *Statistically significantly worse versus SM Regimen (p = 0.008).

The SM Regimen demonstrated significant improvements from treatment and was evaluated in a diverse population of subjects,
baseline in global assessments of PIH and PIE as early as 48 h, and the study met target enrollment for subjects with PIH/PIE and
which were sustained up to 12 weeks. PIH and PIE occur when with darker skin types. Limitations include that this was a single-­
acne inflammation results in overproduction of melanin or capil- center study and the lack of an adolescent cohort. It is possible that
lary damage, respectively [23]. Although PIE is more common in observed benefits of the SM Regimen could extend to adolescents
lighter skin (FST I–III), PIH can occur with any skin type but may because the etiology of acne may be similar in adults and adoles-
be more prevalent and prominent in darker skin [10, 24]. Skin irri- cents. Additional research is warranted in larger, multi-­site studies
tation associated with acne treatment may worsen PIH in patients to evaluate the effectiveness and tolerability of the SM Regimen in
with skin of color or contribute to erythema [23]. The current find- adolescents with acne. Also, the small sample size could be a po-
ings suggest that the SM Regimen, which can be used alone or in tential study limitation; however, the number of patients enrolled
combination with a spot treatment [25], may help address the need in this study aligns with other studies investigating safety and effi-
for gentle and effective acne treatments that reduce PIH and PIE. cacy of topical acne products [12].

Most subjects (> 96%) reported high treatment satisfaction and In this randomized study of adults with acne, the SM Regimen
favorable tolerability with the SM Regimen, including in pa- effectively reduced acne severity and skin oiliness while evening
rameters associated with skin dryness. Current acne treatment out skin tone without overdrying or irritating the skin. Most
formulations can have adverse events, such as dryness and skin subjects (> 96%) reported high satisfaction with the SM Regimen
irritation, that limit tolerability and treatment adherence [11]. at all time points, suggesting it may help address the need for an
In addition, adults often have additional needs related to skin effective acne treatment that respects the needs of adult skin.
aging, such as reduced barrier function, impaired hydration, and
changes in skin quality (e.g., larger pores; wrinkles; dull, blotchy,
and rough skin; hyperpigmentation; erythema; and dryness) [26]. Author Contributions
Study design: Priscilla Huang, Elizabeth T. Makino, and Rahul C.
The SM Regimen takes a multifactorial approach to acne con- Mehta. Principal investigator: Elizabeth T. Makino. Study investigator:
trol, considering the needs of adult skin. Specifically, ingredi- Cecilia L. Pak. Enrolled patients: Cecilia L. Pak. Collection and assem-
ents in the SM Regimen, including bakuchiol, niacinamide, bly of data: Cecilia L. Pak. Data analysis: Cecilia L. Pak. Data interpre-
and a synergistic complex of chaulmoogra, black cumin, ma- tation: All authors. Manuscript review and revisions: All authors. Final
nuka, and magnolia, help address acne without drying the skin approval of manuscript: All authors.
and work to restore and maintain a good balance of sebum.
Overabundance of sebum can promote acne-­ related inflam- Acknowledgments
mation, as oxidation of lipids in sebum triggers the release of Medical writing support was provided by Illyce Nuñez, PhD of Peloton
inflammatory mediators in the skin [27]. An imbalance of ox- Advantage, LLC, an OPEN Health company, and funded by Allergan
idants and antioxidants in acne-­prone skin contributes to this Aesthetics, an AbbVie Company. All authors met the ICMJE authorship
process [27]. Ingredients with antioxidant properties, such as criteria. Neither honoraria nor other forms of payment were made for
bakuchiol and niacinamide, were included in the SM Regimen authorship.
with the aim of restoring this balance, preventing sebum oxida-
tion, and reducing inflammation. Ethics Statement
The authors confirm that the ethical policies of the journal, as noted
Strengths of this study include that the SM Regimen was com- on the journal's author guidelines page, have been adhered to and the
pared with the gold standard prescription combination topical appropriate ethical review committee approval has been received. The

8 of 10 Journal of Cosmetic Dermatology, 2024

 14732165, 0, Downloaded from https://onlinelibrary.wiley.com/doi/10.1111/jocd.16568 by Yemen Hinari NPL, Wiley Online Library on [20/11/2024]. See the Terms and Conditions (https://onlinelibrary.wiley.com/terms-and-conditions) on Wiley Online Library for rules of use; OA articles are governed by the applicable Creative Commons License
study was approved by an institutional review board (Advarra IRB, 8. V. Goulden, G. I. Stables, and W. J. Cunliffe, “Prevalence of Facial
Columbia, MD, USA) and conducted in accordance with all applicable Acne in Adults,” Journal of the American Academy of Dermatology 41
guidelines for the protection of human subjects for research as required (1999): 577–580.
by 21 Code of Federal Regulations (CFR) 50.25 and the accepted stan-
9. E. Markiewicz, N. Karaman-­Jurukovska, T. Mammone, and O. C.
dards for Good Clinical Practice.
Idowu, “Post-­Inflammatory Hyperpigmentation in Dark Skin: Molec-
ular Mechanism and Skincare Implications,” Clinical, Cosmetic and
Consent Investigational Dermatology 15 (2022): 2555–2565.
All patients have provided written informed consent for their photos to 10. E. C. Davis and V. D. Callender, “Postinflammatory Hyperpigmen-
be published. tation: A Review of the Epidemiology, Clinical Features, and Treatment
Options in Skin of Color,” Journal of Clinical and Aesthetic Dermatology
3 (2010): 20–31.
Conflicts of Interest
11. A. L. Zaenglein, A. L. Pathy, B. J. Schlosser, et al., “Guidelines of
Priscilla Huang: employee of Allergan Aesthetics, an AbbVie Company,
Care for the Management of Acne Vulgaris,” Journal of the American
and may own AbbVie stock. Olivia Supan: employee of Allergan
Academy of Dermatology 74, no. 945–973 (2016): e933.
Aesthetics, an AbbVie Company, and may own AbbVie stock. Cecilia L.
Pak: employee of SGS Stephens Inc. Rahul C. Mehta: former employee 12. H. Liu, H. Yu, J. Xia, et al., “Topical Azelaic Acid, Salicylic Acid,
of Allergan Aesthetics, an AbbVie Company, and may own AbbVie Nicotinamide, Sulphur, Zinc and Fruit Acid (Alpha-­Hydroxy Acid) for
stock. Elizabeth T. Makino: employee of Allergan Aesthetics, an AbbVie Acne,” Cochrane Database of Systematic Reviews 5 (2020): CD011368.
Company, and may own AbbVie stock.
13. Galderma Laboratories, 2013, Epiduo Gel (Package Insert), Fort
Worth, TX: Galderma Laboratories, L.P.
Data Availability Statement
14. P. Andres, C. Pernin, and M. Poncet, “Adapalene-­Benzoyl Peroxide
The data that support the findings of this study are available from the Once-­Daily, Fixed-­Dose Combination Gel for the Treatment of Acne
corresponding author upon reasonable request. Vulgaris: A Randomized, Bilateral (Split-­Face), Dose-­A ssessment Study
of Cutaneous Tolerability in Healthy Participants,” Cutis 81 (2008):
Data sharing: AbbVie is committed to responsible data sharing re-
278–284.
garding the clinical trials we sponsor. This includes access to ano-
nymized, individual, and trial-­level data (analysis data sets), as well 15. S. Adhikari, R. Joshi, B. S. Patro, et al., “Antioxidant Activity of Ba-
as other information (e.g., protocols, clinical study reports, or analy- kuchiol: Experimental Evidences and Theoretical Treatments on the
sis plans), as long as the trials are not part of an ongoing or planned Possible Involvement of the Terpenoid Chain,” Chemical Research in
regulatory submission. This includes requests for clinical trial data Toxicology 16 (2003): 1062–1069.
for unlicensed products and indications. These clinical trial data can
16. M. L. Ferrándiz, B. Gil, M. J. Sanz, et al., “Effect of Bakuchiol on
be requested by any qualified researchers who engage in rigorous, in-
Leukocyte Functions and Some Inflammatory Responses in Mice,”
dependent, scientific research, and will be provided following review
Journal of Pharmacy and Pharmacology 48 (1996): 975–980.
and approval of a research proposal, Statistical Analysis Plan (SAP),
and execution of a Data Sharing Agreement (DSA). Data requests 17. H. Katsura, R. I. Tsukiyama, A. Suzuki, and M. Kobayashi, “In Vitro
can be submitted at any time after approval in the United States and Antimicrobial Activities of Bakuchiol Against Oral Microorganisms,”
Europe and after acceptance of this manuscript for publication. The Antimicrobial Agents and Chemotherapy 45 (2001): 3009–3013.
data will be accessible for 12 months, with possible extensions consid-
18. B. Sun, L. Wu, Y. Wu, et al., “Therapeutic Potential of Centella Asiat-
ered. For more information on the process or to submit a request, visit
ica and Its Triterpenes: A Review,” Frontiers in Pharmacology 11 (2020):
the following link: https://​v ivli.​org/​ourme​mber/​abbvie/​ then select
568032.
“Home.”
19. M. Lovászi, A. Szegedi, C. C. Zouboulis, and D. Törőcsik,
“Sebaceous-­
Immunobiology Is Orchestrated by Sebum Lipids,”
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