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

NCT ID: NCT07015931

Last Updated: 2025-06-11

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 23 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-11-30
• Study Completion Date: 2025-03-15

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.

Conditions

Acne Vulgaris

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Treatment with 0.025% Retinoic Acid Cream (Split-Face Design)

Participants will apply 0.025% retinoic acid cream half finger tip unit on one randomized side of the face every night for 12 weeks.

Group Type: EXPERIMENTAL

retinoic acid cream 0.025%

Intervention Type: DRUG

half finger tip unit

Treatment with 0.1% Adapalene Cream (Split-Face Design)

Participants will apply 0.1% adapalene cream half finger tip unit on one randomized side of the face every night for 12 weeks.

Group Type: EXPERIMENTAL

adapalene cream 0.1%

Intervention Type: DRUG

half finger tip unit

Interventions

retinoic acid cream 0.025%

half finger tip unit

Intervention Type: DRUG

adapalene cream 0.1%

half finger tip unit

Intervention Type: DRUG

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.

• Minimum Eligible Age: 15 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Indonesia University

OTHER

Sponsor Role: lead

Responsible Party

Reisa Reshinta

MD

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Cipto Mangunkusumo National Hospital

Jakarta, DKI Jakarta, Indonesia

Countries

Indonesia

Other Identifiers

24-08-1369

Identifier Type: -

Identifier Source: org_study_id