Acne Vulgaris
Conditions
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
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.
Interventions
DRUGretinoic acid cream 0.025%
half finger tip unit
half finger tip unit
Sponsors
Indonesia University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
15 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group | from enrollment to the end of treatment at 12 weeks | The percentage reduction was calculated by comparing the total number of lesions at 12 weeks to baseline counts |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Severity profile of adverse effects | from enrollment to the end of treatment at 12 weeks | 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. |
| Hyperpigmentation index profile | from enrollment to the end of treatment at 12 weeks | 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. |
| Post acne erythema profile | from enrollment to the end of treatment at 12 weeks | 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. |
| Profile of post-acne scar type | from enrollment to the end of treatment at 12 weeks | 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. |
| Severity profile of post acne scarring | from enrollment to the end of treatment at 12 weeks | 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. |
Countries
Indonesia
Outcome results
None listed