Acne VulgarisPhase 1/2NCT07015931
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
A Phase 1/2 study testing retinoic acid cream 0.025% and adapalene cream 0.1% in people with Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- retinoic acid cream 0.025% and adapalene cream 0.1%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 23 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Nov 2024to 15 Mar 2025
- Phase
- Phase 1/2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Cipto Mangunkusumo National Hospital
Jakarta, DKI Jakarta, 10430
About this study
Official 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
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:
Read more
- 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.
- Conditions
- Acne Vulgaris
- Being tested
- retinoic acid cream 0.025%, adapalene cream 0.1%
- 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
- Medical subject headings
- Acne Vulgaris, Hyperpigmentation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
retinoic acid cream 0.025%Drug
half finger tip unit
adapalene cream 0.1%Drug
half finger tip unit
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: adapalene cream 0.1% |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: from enrollment to the end of treatment at 12 weeks
Secondary outcomes (5)
Severity profile of adverse effects
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.
Measured: from enrollment to the end of treatment at 12 weeks
Hyperpigmentation index profile
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.
Measured: from enrollment to the end of treatment at 12 weeks
Post acne erythema profile
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.
Measured: from enrollment to the end of treatment at 12 weeks
Profile of post-acne scar type
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.
Measured: from enrollment to the end of treatment at 12 weeks
Severity profile of post acne scarring
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.
Measured: from enrollment to the end of treatment at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2025
- Study start30 Nov 2024
- Primary completion8 Mar 2025
- Study completion15 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 23 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reisa Reshinta, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07015931
- Sponsor's protocol ID
- 24-08-1369
- Status last verified
- Jun 2025
- First submitted
- 26 May 2025
- Last updated
- 11 Jun 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jun 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT07015931
- Acronym / sponsor ID
- 24-08-1369
- 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
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 23 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Nov 2024 (actual)
- Primary completion
- 8 Mar 2025 (actual)
- Study completion
- 15 Mar 2025 (actual)
- First posted
- 11 Jun 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with 0.025% Retinoic Acid Cream (Split-Face Design) | Experimental | Drug: retinoic acid cream 0.025%Participants will apply 0.025% retinoic acid cream half finger tip unit on one randomized side of the face every night for 12 weeks. |
| Treatment with 0.1% Adapalene Cream (Split-Face Design) | Experimental | Drug: adapalene cream 0.1%Participants will apply 0.1% adapalene cream half finger tip unit on one randomized side of the face every night for 12 weeks. |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| retinoic acid cream 0.025%half finger tip unit | Drug | Treatment with 0.025% Retinoic Acid Cream (Split-Face Design) |
| adapalene cream 0.1%half finger tip unit | Drug | Treatment with 0.1% Adapalene Cream (Split-Face Design) |
Primary outcome
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
5 secondary outcomes
Severity profile of adverse effects
Time frame: from enrollment to the end of treatment at 12 weeks
Hyperpigmentation index profile
Time frame: from enrollment to the end of treatment at 12 weeks
Post acne erythema profile
Time frame: from enrollment to the end of treatment at 12 weeks
Profile of post-acne scar type
Time frame: from enrollment to the end of treatment at 12 weeks
Severity profile of post acne scarring
Time frame: from enrollment to the end of treatment at 12 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jun 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing retinoic acid cream 0.025% and adapalene cream 0.1% in people with Acne Vulgaris, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Jun 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Jun 2025; AzTrials last refreshed its copy on 7 Nov 2026.