CTRI/2025/07/090262 [Registered on: 07/07/2025] Trial Registered Prospectively
Last Modified On:
01/06/2026
Post Graduate Thesis
No
Type of Trial
Interventional
Type of Study
Drug
Study Design
Randomized, Parallel Group, Active Controlled Trial
Public Title of Study
A clinical study to assess the efficacy and safety of Clascoterone Cream in patients with pimples.
Scientific Title of Study
A Multicentric, Randomized, Prospective, Active-Controlled, Parallel Group, Evaluator Blind, Comparative and Phase III Clinical Study to Evaluate the Efficacy, Safety and Tolerability of Clascoterone Cream 1 percentage w/w in Comparison with Adapalene Gel 0.1 percentage w/w in the Treatment of Patients with Acne Vulgaris.
Trial Acronym
NIL
Secondary IDs if Any
Secondary ID
Identifier
CT/2024/04, Version No.: 01 and Dated Sep 23, 2024
Protocol Number
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Scientific Query
Name
Dr Rajasekhara Reddy Tamma
Designation
Managing Director
Affiliation
Clinwave Research Pvt. Ltd.
Address
Clinwave Research Pvt. Ltd.,
LIG: B/466, H. No.: 1-16-10/466, Dr. A.S. Rao Nagar, Kapra, Medchal-Malkajgiri (Dist.).
Medchal TELANGANA 500062 India
Phone
7989233379
Fax
Email
dr.sekhar@clinwave.co.in
Details of Contact Person Public Query
Name
Mr Sidharth Vasistha
Designation
Managing Partner
Affiliation
Om Sai Pharma Pack
Address
Om Sai Pharma Pack,
Plot No. 38 & 39, Sector-11, I.I.E., SIDCUL, Haridwar.
Hardwar UTTARANCHAL 249403 India
Phone
9910038888
Fax
Email
sidharth@pentagroup.in
Source of Monetary or Material Support
Om Sai Pharma Pack, Plot No. 38 & 39, Sector-11, I.I.E., SIDCUL, Haridwar-249403, Uttarakhand, India.
Institutional Ethics Committee, Subharti Medical College and Hospital
Approved
Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College Institutional Ethics Committee 2 (RCSMGMCIEC2), Rajarshee Chhatrapati Shahu Maharaj Govt. Medical College and Chhatrapati Pramila Raje General Hospital
Approved
Redkar Hospital Institutional Ethics Committee (RHIEC), Redkar Hospital and Research Centre
Approved
Sangini Hospital Ethics Committee C/o Sangini Hospital - Hope Well Medical Hospital
Approved
SMC Heart Institute Institutional Ethics Committee
Approved
Regulatory Clearance Status from DCGI
Status
Approved/Obtained
Health Condition / Problems Studied
Health Type
Condition
Patients
(1) ICD-10 Condition: L700||Acne vulgaris,
Intervention / Comparator Agent
Type
Name
Details
Comparator Agent
Adapalene Gel 0.1% w/w
Patients will be advised to apply a thin film to the affected areas once a day before bedtime. The affected areas should be dry before application.
Intervention
Clascoterone Cream 1% w/w
Patients will be advised to apply a thin layer (approximately 1 gram) to the affected area twice daily (morning and evening) around same time every day for 12 weeks. The affected areas should be dry before application.
Inclusion Criteria
Age From
12.00 Year(s)
Age To
65.00 Year(s)
Gender
Both
Details
1. Male or female patients aged between 12 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris.
2. Patient has an Investigator’s Global Assessment (IGA) score of 2 (mild) or 3 (moderate) at the screening or baseline visit.
3. Patients with facial acne vulgaris, with at least 20 to a maximum of 50 inflammatory lesions (papules and pustules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones).
4. Women of childbearing potential (WOCBP) must be using an acceptable method of contraception to avoid pregnancy throughout the study. WOCBP must have a negative urine pregnancy test at screening or baseline visit.
5. Patients agree not to use any product on the face during the entire course of study except for non-medicated, investigator-approved cleanser, sunscreen, face wash and make-up. Subjects should continue to use these investigator-approved products for the duration of the study and should avoid any changes in these consumer products.
6. Patient with ability to understand and provide written, signed and dated informed consent form (for patients aged between more than or equal to 18 to less than or equal to 65 years) or assent form (for patients aged between more than or equal to 12 to less than 18 years), which must have been obtained prior to screening.
7. Patients willing to comply with all the protocol requirements throughout the study.
ExclusionCriteria
Details
1. Female patients who are pregnant or lactating or planning to become pregnant during the study period.
2. Female patients who are of childbearing potential and who are neither surgically sterilized nor willing to use reliable contraceptive methods (like hormonal, barrier methods or intrauterine device).
3. Patients with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
4. Patients with excessive facial hair (e.g., heavy beards or moustaches), facial tattoos or facial disfigurement that would interfere with diagnosis or assessment of acne vulgaris.
5. Patient has greater than two (2) facial nodules.
6. Patient has nodulocystic acne.
7. Patient has known hypersensitivity or previous allergic reaction to any of the study medication.
8. Patient has used any of the following products:
a)Topical acne treatments (retinoids, antibiotics, Benzoyl Peroxide, Azelaic Acid, Resorcinol, salicylates, α-hydroxy/glycolic acid), or other topical facial medication (antifungals, steroids, anti-inflammatories) on the treatment area in the 14 days prior to the baseline visit, including prescription and non-prescription products.
b)Systemic corticosteroids, systemic acne treatments including systemic antibiotics used for treatment of acne, potential photosensitizing agents (thiazides, phenothiazines), Spironolactone, Flutamide, or immunosuppressant drugs in the 30 days prior to the baseline visit.
c)Systemic retinoid use (including high dose vitamin A more than 10,000 units per day) in the 180 days prior to the baseline visit.
d)Undertaken certain facial procedures such as chemical peel, laser treatment, photodynamic therapy, acne surgery, cryodestruction or chemodestruction, x-ray therapy, intralesional steroids, dermabrasion, or depilation (except eyebrow shaping) in the 30 days prior to the baseline visit. After the subject is enrolled in the study, eyebrow shaping (except for tweezing) is prohibited.
e)Treatment with a medication or procedure that, in the opinion of the investigator, would put the subject at unacceptable risk for participation in the study or may interfere with evaluations in the study.
9. Patients with clinically significant impaired hepatic function (SGOT & SGPT more than 3X the UNL) at screening.
10. Patients with uncontrolled hypertension with sitting systolic BP more than or equal to 160 mmHg and/or diastolic BP more than or equal to 100 mmHg at screening.
11. Patient has any abnormality on 12-lead ECG at screening that in the opinion of the investigator is clinically significant and is judged as potential risk for patient’s participation in the study.
12. Patients with a history of experiencing significant burning or stinging when applying any facial treatment (e.g., make-up, soap, masks, washes, sunscreens, etc.) to their face.
13. Patients who have used estrogens or oral contraceptives within 4 weeks prior to randomization.
14. Patients with a serious and/or chronic medical condition such as chronic or active liver disease, renal impairment, heart disease, severe respiratory disease, rheumatoid arthritis, current malignancies, immunocompromised conditions, or any other disease that, in the opinion of the investigator, would interfere with the study or place the subject at unacceptable risk.
15. Patients with a history of substance abuse or dependence that in the opinion of the Investigator is considered to interfere with the patient’s participation in the study.
16. Patients with concurrent participation in another clinical trial or any investigational therapy within 30 days prior to signing informed consent or assent.
17. Patients currently taking any of the prohibited medications(s) and inability/unwillingness to discontinue them for the entire study period.
18. Patients with suspected inability or unwillingness to comply with the study procedures.
19. Patient with any condition which, in the judgment of the Investigator, may render the patient unable to complete the study or which may pose a significant risk to the patient.
Method of Generating Random Sequence
Computer generated randomization
Method of Concealment
Not Applicable
Blinding/Masking
Outcome Assessor Blinded
Primary Outcome
Outcome
TimePoints
Proportion of patients in each treatment group achieving success at Week 12 (success defined as IGA score of clear (score zero) or almost clear (score one) and/or at least a two-point reduction in IGA score compared to baseline).
Baseline (Visit 1) and Week 12 (Visit 6).
Secondary Outcome
Outcome
TimePoints
Mean change from baseline to week 12 in inflammatory lesion (papules and pustules) count.
Changes in clinical laboratory parameters from baseline to end of the study visit (week 12).
Baseline (Visit 1) and Week 12 (Visit 6).
Target Sample Size
Total Sample Size="228" Sample Size from India="228" Final Enrollment numbers achieved (Total)= "228" Final Enrollment numbers achieved (India)="228"
Phase of Trial
Phase 3
Date of First Enrollment (India)
01/08/2025
Date of Study Completion (India)
06/02/2026
Date of First Enrollment (Global)
Date Missing
Date of Study Completion (Global)
Date Missing
Estimated Duration of Trial
Years="1" Months="0" Days="0"
Recruitment Status of Trial (Global)
Not Applicable
Recruitment Status of Trial (India)
Completed
Publication Details
N/A
Individual Participant Data (IPD) Sharing Statement
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
Brief Summary
This trial is a multicentric, randomized, prospective, active-controlled, parallel group, evaluator blind, comparative and phase III clinical study to evaluate the efficacy, safety and tolerability of Clascoterone Cream 1% w/w in comparison with Adapalene Gel 0.1% w/w in the treatment of patients with acne vulgaris.
Patients who are willing and able to participate in the study will sign and date the Informed Consent or Assent Form on the day of screening / baseline visit (Visit 1). During this screening period, patients who are willing to give consent or assent will be evaluated for all the eligibility criteria. Eligible patients (male or female) aged between 18 to 65 years (both inclusive) with a clinical diagnosis of acne vulgaris, who have a score of 2 (mild) or 3 (moderate) on the Investigator’s Global Assessment (IGA) at the screening / baseline visit, has facial acne vulgaris, with at least 20 to a maximum of 50 inflammatory lesions (papules and pustules) and 30 to a maximum of 100 non-inflammatory lesions (open and closed comedones) will be considered for the study.
After confirming the inclusion/exclusion criteria the patients will be randomized and provided with study medication at randomization visit. Patients will be provided with a diary at randomization visit, which need to be brought along in each subsequent visit till the last visit. Follow up visits will be done on week 2/day 14(±3), week 4/day 28(±3), week 8/day 56(±3) and week 12/day 84(±3) (Final Visit) of treatment to assess efficacy, safety and tolerability.
Patients will be assigned to either of the two arms i.e., Arm A or Arm B consisting of Clascoterone Cream 1% w/w or Adapalene Gel 0.1% w/w. (Arm A) Patients will be advised to apply a thin layer (approximately 1 gram) to the affected area twice daily (morning and evening) around same time every day for 12 weeks. (Arm B) Patients will be advised to apply a thin film to the affected areas once a day before bedtime. The affected areas should be dry before application.