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

University of Indonesia (UI)

Status and phase

Completed

Phase 2

Phase 1

Conditions

Acne Vulgaris

Treatments

Drug: retinoic acid cream 0.025%

Drug: adapalene cream 0.1%

Study type

Interventional

Funder types

Other

Identifiers

NCT07015931

24-08-1369

Details and patient eligibility

About

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:

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?
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?
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?
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?
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.

Enrollment

23 patients

Sex

All

Ages

15+ years old

Volunteers

No Healthy Volunteers

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.