Acne VulgarisEarly Phase 1NCT07673094
Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris
A Early Phase 1 study testing Clascoterone Cream 1% and Adapalene 0,1% cgel in people with Acne Vulgaris, run by Khyber Teaching Hospital.
Trial summary
There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient… Read more about this study
- Who is it for?
- Ages 12 to 35 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Clascoterone Cream 1% and Adapalene 0,1% cgel
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- No sites listed yet
- Study dates
- 15 Aug 2026to 22 Aug 2027
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 12 to 35 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Clinical diagnosis of mild acne vulgaris as per operational definition
- Male or female patients
- Age 12 to 35 years
Who cannot join
- History of acne conglobata
- History of acne fulminans
- Use of topical anti-acne medications within the last 4 weeks
- Use of systemic anti-acne therapy within the last 12 weeks
- Known hypersensitivity or allergy to clascoterone or adapalene
- History of eczema
Show all 12Show fewer
- History of rosacea
- History of seborrheic dermatitis
- History of psoriasis
- Presence of active skin infections
- Pregnant women
- Lactating women
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Comparison of Efficacy of Topical Clascoterone With Topical Adapalene in the Treatment of Mild Acne Vulgaris
There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.
Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.
Read more
Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).
Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.
Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.
- Conditions
- Acne Vulgaris
- Being tested
- Clascoterone Cream 1%, Adapalene 0,1% cgel
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Clascoterone Cream 1%Drug
Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.
Adapalene 0,1% cgelDrug
Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.
| Study group | Role | What they receive |
|---|---|---|
| topical CLASCOTERONE 1 percent cream | Experimental | Not described Receives: Drug: Clascoterone Cream 1%; Drug: Adapalene 0,1% cgel |
| Topical adapalene 0.1 percent gel | Active comparator | Not described Receives: Drug: Clascoterone Cream 1%; Drug: Adapalene 0,1% cgel |
What is being measured
The primary outcome is the main question the study is designed to answer.
IGA achievement
investigator global assessment achievement of 0 which is clear face or 1 which is almost clear
Measured: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment
Investigator global assessment scoring
Measured: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2026
- Study start15 Aug 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completion22 Aug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acne VulgarisStudies of the same condition, open and under way.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Khyber Teaching Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Haider Ali, Khyber Teaching Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07673094
- Sponsor's protocol ID
- 383/IREB/KTH
- Status last verified
- Jun 2026
- First submitted
- 18 Jun 2026
- Last updated
- 29 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6.
PubMed 38030667Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec.
PubMed 38076662
Study at a glance
From the registry record, last updated by the sponsor on 29 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Efficacy of Topical Clascoterone With Topical Adapalene in the Treatment of Mild Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07673094
- Acronym / sponsor ID
- 383/IREB/KTH
- Conditions
- Acne Vulgaris
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Khyber Teaching HospitalUniversity, hospital or other
- Study start
- 15 Aug 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- 22 Aug 2027 (estimated)
- First posted
- 29 Jun 2026 (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.
There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.
Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.
Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).
Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.
Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| topical CLASCOTERONE 1 percent cream | Experimental | Drug: Clascoterone Cream 1%, Drug: Adapalene 0,1% cgel |
| Topical adapalene 0.1 percent gel | Active comparator | Drug: Clascoterone Cream 1%, Drug: Adapalene 0,1% cgel |
Who may qualify
- Ages
- 12 to 35 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Clinical diagnosis of mild acne vulgaris as per operational definition
- Male or female patients
- Age 12 to 35 years
Key exclusion criteria (12 listed)
- History of acne conglobata
- History of acne fulminans
- Use of topical anti-acne medications within the last 4 weeks
- Use of systemic anti-acne therapy within the last 12 weeks
- Known hypersensitivity or allergy to clascoterone or adapalene
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 |
|---|---|---|
| Clascoterone Cream 1%Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study. | Drug | Topical adapalene 0.1 percent gel, topical CLASCOTERONE 1 percent cream |
| Adapalene 0,1% cgelParticipants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study. | Drug | Topical adapalene 0.1 percent gel, topical CLASCOTERONE 1 percent cream |
Primary outcome
IGA achievement
Time frame: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
investigator global assessment achievement of 0 which is clear face or 1 which is almost clear
Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment
Time frame: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
Investigator global assessment scoring
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jun 2026.
- Results publication: PubMed 38030667Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6.
- Results publication: PubMed 38076662Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Clascoterone Cream 1% and Adapalene 0,1% cgel in people with Acne Vulgaris, run by Khyber Teaching Hospital.
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 3 inclusion and 12 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: opening soon, as of the sponsor's last update on 29 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
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 phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Haider Ali, MBBS,CHR (+923018078258, drhaider1001@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
IGA achievement (time frame: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07673094, which also lists 2 linked publications.
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 29 Jun 2026.