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Not yet recruitingNCT07673094Updated Jun 29, 2026

Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris

An Early Phase 1 interventional study of Clascoterone Cream 1% and Adapalene 0,1% cgel in Acne Vulgaris, sponsored by Khyber Teaching Hospital. Not yet recruiting. Open to participants aged 12 Years to 35 Years. Per ClinicalTrials.gov, last updated 2026-06-29.

Sponsored by Khyber Teaching Hospital · Early Phase 1, Interventional, and Treatment

Phase
Early Phase 1
Study type
Interventional
Enrollment
60
Allocation
Randomized
Ages
12 Years to 35 Years
Sex
All
01

Study 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 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.

02

Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

790 studies on the registry are indexed under Acne Vulgaris; 93 are open to participants now.

This study's planned enrollment of 60 is below the median of 70 across 672 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Khyber Teaching Hospital is the lead sponsor of 29 studies on the registry; 19 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
12 Years to 35 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Clinical diagnosis of mild acne vulgaris as per operational definition
  • Male or female patients
  • Age 12 to 35 years

Exclusion criteria

Exclusion Criteria:

  • 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 or allergy to clascoterone or adapalene
  • History of eczema
  • History of rosacea
  • History of seborrheic dermatitis
  • History of psoriasis
  • Presence of active skin infections
  • Pregnant women
  • Lactating women
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Hypersensitivity

An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.

05

Study design

Phase
Early Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Single group
Masking
None (open label)
Enrollment
60 participants (estimated)

Study arms

  • Experimental
    topical CLASCOTERONE 1 percent cream

    Drug: Clascoterone Cream 1% · Drug: Adapalene 0,1% cgel

  • Active comparator
    Topical adapalene 0.1 percent gel

    Drug: Clascoterone Cream 1% · Drug: Adapalene 0,1% cgel

Interventions

  • Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.

  • DrugAdapalene 0,1% cgel

    Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.

06

What researchers measure

Primary outcomes

  1. IGA achievement

    investigator global assessment achievement of 0 which is clear face or 1 which is almost clear

    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.

  2. Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment

    Investigator global assessment scoring

    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.

07

Study locations

No study locations are listed for this record.

08

References and documents

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 38030667 ↗
  • Vasam 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 ↗

Individual participant data

Plan to share: No

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Aug 2026; primary completion for Feb 2027, 6 months later.

Of 51 phase 1 interventional studies under Acne Vulgaris, half reached primary completion within 5 months of starting (the median), counting those still running; a quarter within 2 and three quarters within 10. This study's planned 6 months is above that.

How these figures are worked out, and which studies are left out of them.

Registered
Jun 18, 2026
First posted
Jun 29, 2026
StartEst.
Aug 15, 2026
Primary completionEst.
Feb 2027
CompletionEst.
Aug 22, 2027
Last update
Jun 29, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jun 29, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07673094
Lead sponsor
Khyber Teaching Hospital
Responsible party
Haider Ali (Principal investigator, Khyber Teaching Hospital) — Principal investigator
First posted
Jun 29, 2026
Start date
Aug 15, 2026 (estimated)
Primary completion
Feb 2027 (estimated)
Completion
Aug 22, 2027 (estimated)
Last update
Jun 29, 2026

Study contacts

Haider Ali, MBBS,CHR
Contact
drhaider1001@gmail.com
+923018078258

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

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Discussion

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Studies of the drug tested here: Clascoterone

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