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

NCT07015931 | Completed Phase 1 DMC

• 1 other identifier: 24-08-1369
• Study Type: interventional
• Target: 23
• Locations: 1 country
• Sites: 1

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:

• 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

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

Outcome Measures

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

  The percentage reduction was calculated by comparing the total number of lesions at 12 weeks to baseline counts

  from enrollment to the end of treatment at 12 weeks

Secondary Outcomes (5)

• Severity profile of adverse effects

  from enrollment to the end of treatment at 12 weeks

• Hyperpigmentation index profile

  from enrollment to the end of treatment at 12 weeks

• Post acne erythema profile

  from enrollment to the end of treatment at 12 weeks

• Profile of post-acne scar type

  from enrollment to the end of treatment at 12 weeks

• Severity profile of post acne scarring

  from enrollment to the end of treatment at 12 weeks

Study Arms (2)

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

EXPERIMENTAL

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

Drug: retinoic acid cream 0.025%

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

EXPERIMENTAL

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

Drug: adapalene cream 0.1%

Interventions

retinoic acid cream 0.025% DRUG

half finger tip unit

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

adapalene cream 0.1% DRUG

half finger tip unit

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

Eligibility Criteria

• Age: 15 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Indonesia University: lead

Study Sites (1)

Cipto Mangunkusumo National Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

MeSH Terms

Conditions

Acne Vulgaris; Hyperpigmentation

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Pigmentation Disorders

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: May 26, 2025
• First Posted: June 11, 2025
• Study Start: November 30, 2024
• Primary Completion: March 8, 2025
• Study Completion: March 15, 2025
• Last Updated: June 11, 2025

Record last verified: 2025-06

Locations

ID (1)