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Completed

NCT Number: 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

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.

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Key information

Conditions

Acne Vulgaris Acneiform Eruptions Hyperpigmentation Pigmentation Disorders Sebaceous Gland Diseases Skin Diseases Skin and Connective Tissue Diseases

Age range

15 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Cipto Mangunkusumo National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

retinoic acid cream 0.025%

Drug

half finger tip unit

adapalene cream 0.1%

Drug

half finger tip unit

Primary outcomes

  1. Comparison of the percentage reduction in total acne lesions between the 0.025% tretinoin cream group and the 0.1% adapalene cream group

    Time frame: 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 outcomes

  1. Severity profile of adverse effects

    Time frame: 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.

  2. Hyperpigmentation index profile

    Time frame: 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.

  3. Post acne erythema profile

    Time frame: 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.

  4. Profile of post-acne scar type

    Time frame: 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.

  5. Severity profile of post acne scarring

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Indonesia University

Other

Registry information

Official study 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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Jun 11, 2025
Registry last updated
Jun 11, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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