Clinical trial NCT07015931: Efficacy, Safety Profile, and Post-Acne Sequelae of 0.025% Retinoic Acid Cream vs. 0.1% Adapalene Cream in Mild Acne Vulgaris in Fitzpatrick Skin Types III-V
Official title: Efficacy of 0.025% Retinoic Acid Cream Compared to 0.1% Adapalene Cream on Mild Acne Vulgaris, as Well as Safety Profile and Post-Acne Sequelae in Fitzpatrick Skin Types III-V: A Randomized Double-Blind Clinical Trial Using the Split-Face Method
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Acne Vulgaris
Keywords: acne vulgaris
mild acne
retinoic acid 0.025%
adapalene 0.1%
topical retinoids
acne treatment
Fitzpatrick skin type III-V
post inflammatory hyperpigmentation
post acne erythema
post acne scarring
adverse effects of retinoids
clinician erythema assessment
randomized controlled trial
acne lesion count
acne sequelae
Lead sponsor: Indonesia University
Sponsor class: OTHER
First posted: 2025-06-11
Enrollment: 23
Sex: ALL
Minimum age (years): 15
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The goal of this clinical trial is to compare the effectiveness, safety profile, and post-acne sequelae of 0.025% retinoic acid cream versus 0.1% adapalene cream for mild acne vulgaris in individuals with Fitzpatrick skin types III-V.

Main research questions are:

1. How does 0.025% retinoic acid cream compare to 0.1% adapalene cream in reducing the total number of acne lesions in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
2. What is the severity of adverse effects that occur on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
3. What is the severity of post-inflammatory hyperpigmentation (PIH) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
4. What is the severity of post-acne erythema (PAE) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?
5. What is the quantity, type, and severity of post-acne scarring (PAS) that occurs on the facial side treated with 0.1% adapalene cream and the facial side treated with 0.025% retinoic acid cream in patients with mild acne vulgaris and Fitzpatrick skin types III-V?

Participants will:

* Undergo baseline assessments, including acne lesion count, hyperpigmentation index, Clinician Erythema Assessment (CEA) scale, and post-acne scarring grading on each facial side.
* Apply 0.025% retinoic acid cream and 0.1% adapalene cream on different facial sides as per randomization, every night for 12 weeks.
* Record daily adverse effects per facial side, lesion manipulation frequency, and sun exposure duration
* Attend follow-up visits every 4 weeks for acne lesion count, hyperpigmentation index, CEA scale, post-acne scarring grading, and assessment of adverse effect severity.


Eligibility criteria: Inclusion Criteria:

* Clinical diagnosis of mild acne vulgaris, defined as fewer than 20 comedonal lesions, fewer than 15 inflammatory lesions, or a total lesion count of 30 or less, with a difference in total lesion count between the two sides of the face ≤ 5 lesions.
* Minimum age of 15 years.
* Indonesian individuals with Fitzpatrick skin types III-V.
* Willing to participate in the study by signing an informed consent form.

Exclusion Criteria:

* History of routine application of topical agents containing active ingredients on the face within the past 2 weeks.
* History of oral antibiotic use within the past 2 weeks.
* History of systemic retinoid use within the past 3 months.
* Currently pregnant or breastfeeding.
* Using oral contraceptives at the time of assessment.
* Presence of other dermatologic conditions on the face aside from acne vulgaris.
* Having sensitive facial skin classified as rosacea-type, stinging-type, or allergic-type.
* Unwilling to discontinue topical active agent therapy that has been used routinely for at least 2 weeks prior to study participation.

Primary outcomes:
measure: Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group
timeFrame: from enrollment to the end of treatment at 12 weeks
Secondary outcomes:
measure: Severity profile of adverse effects
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Hyperpigmentation index profile
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Post acne erythema profile
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Profile of post-acne scar type
timeFrame: from enrollment to the end of treatment at 12 weeks
measure: Severity profile of post acne scarring
timeFrame: from enrollment to the end of treatment at 12 weeks
Other outcomes:
Locations:
city: Jakarta
country: Indonesia
facility: Cipto Mangunkusumo National Hospital
state: DKI Jakarta
Study officials:
References: