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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
23
half finger tip unit
half finger tip unit
Cipto Mangunkusumo National Hospital
Jakarta, DKI Jakarta, Indonesia
Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group
The percentage reduction was calculated by comparing the total number of lesions at 12 weeks to baseline counts
Time frame: from enrollment to the end of treatment at 12 weeks
Severity profile of adverse effects
Mild: presence of subjective symptoms such as itching or burning sensation without any objective signs (e.g., erythema or desquamation); Moderate: presence of both subjective symptoms and objective signs, but not interfering with daily activities or treatment adherence; Severe: presence of subjective and objective signs that are bothersome and interfere with the patient's comfort or treatment adherence The proportion for each severity grade will be presented as a percentage.
Time frame: from enrollment to the end of treatment at 12 weeks
Hyperpigmentation index profile
The hyperpigmentation index was calculated by multiplying the intensity score of each lesion-assessed using the Taylor Hyperpigmentation Scale-by the total number of lesions. The final index was obtained by averaging the results across all affected sites. The minimum possible score is 0, and the maximum score is 9. A higher score indicates more severe post-acne hyperpigmentation experienced by the study subjects.
Time frame: from enrollment to the end of treatment at 12 weeks
Post acne erythema profile
Post-acne erythema was assessed using the Clinician Erythema Assessment (CEA) scale, which grades erythema severity into five categories: clear, almost clear, mild, moderate, and severe. The proportion for each severity grade will be presented as a percentage.
Time frame: from enrollment to the end of treatment at 12 weeks
Profile of post-acne scar type
The types of post-acne scars recorded included icepick, rolling, boxcar, hypertrophic, keloid, and papular scars. The proportion of each scar type was calculated and will be presented as percentage.
Time frame: from enrollment to the end of treatment at 12 weeks
Severity profile of post acne scarring
Additionally, the severity of post-acne scarring was graded as macular, mild, moderate, or severe based on clinical evaluation. The proportion for each grade will be presented as a percentage.
Time frame: from enrollment to the end of treatment at 12 weeks
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