| CTRI Number |
CTRI/2026/04/109478 [Registered on: 27/04/2026] Trial Registered Prospectively |
| Last Modified On: |
25/04/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
A study comparing two acne creams to see which improves acne better in Indian patients |
|
Scientific Title of Study
|
A Randomized Controlled Trial comparing Topical Adapalene Benzoyl Peroxide Clindamycin Combination versus Topical Adapalene Benzoyl Peroxide Combination in Treatment of Mild to Moderate Acne |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Nasna V |
| Designation |
Junior resident, Dermatology |
| Affiliation |
AIIMS Jammu |
| Address |
Room No 2, OPD division, Department of Dermatology, AIIMS JAMMU
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9539055564 |
| Fax |
|
| Email |
vnasna11@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Payal Chauhan |
| Designation |
Associate Professor, Dermatology |
| Affiliation |
AIIMS Jammu |
| Address |
AIIMS Jammu, Samba district
Jammu and Kashmir
India
184120
AIIMS JAMMU
Vijaypur
Jammu
Jammu and Kashmir
India
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9539055564 |
| Fax |
|
| Email |
payal.chauhan@aiimsjammu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Nasna V |
| Designation |
Junior resident, Dermatology |
| Affiliation |
AIIMS Jammu |
| Address |
Room NO 2, OPD Division, Department of Dermatology, AIIMS Jammu
Jammu and Kashmir
India
184120
Jammu
JAMMU & KASHMIR
184120
India |
| Phone |
9539055564 |
| Fax |
|
| Email |
vnasna11@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AIIMS Jammu |
| Address |
AIIMS Jammu, Vijaypur, Samba DISTRICT, Jammu and Kashmir, India, 184120 |
| Type of Sponsor |
Research institution and hospital |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Nasna V |
AIIMS, JAMMU |
Room No 2, OPD division, Department of Dermatology
Jammu
JAMMU & KASHMIR |
9539055564
vnasna11@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| IEC, AIIMS JAMMU |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L700||Acne vulgaris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Adapalene Benzoyl Peroxide combination gel |
Fixed dose combination topical gel containing Adapalene 0.1 percent and Benzoyl Peroxide 2.5 percent applied topically over face once daily at night for 16 weeks. |
| Intervention |
Fixed-dose gel containing topical Adapalene + Benzoyl Peroxide + Clindamycin |
Fixed combination topical gel containing Adapalene 0.15 percent, Benzoyl Peroxide 3.1 percent and Clindamycin 1.2 percent applied topically on face once daily at night for 16 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male and female patients aged 12-45 years.
Clinical diagnosis of mild (few inflammatory lesions (papules/pustules) only; no nodulocystic lesions; IGA score 2) to moderate (multiple inflammatory lesions present; many papules/pustules; there may or may not be a few nodulocystic lesions, IGA score 3) acne vulgaris.
Willingness to avoid use of other acne medications during the study.
Written informed consent obtained.
|
|
| ExclusionCriteria |
| Details |
Severe acne (Inflammatory lesions are more apparent, many papules,pustules; there may or may not be a few nodulocystic lesions; IGA 4 or more.
Presence of nodulocystic, conglobate, or acne fulminans variants.
Clinical or biochemical features suggestive of hormonal acne, such as polycystic ovarian syndrome (PCOS) or hyperandrogenism.
Use of topical or systemic retinoids, corticosteroids, antibiotics, or hormonal therapy within the previous 4 weeks.
Pregnant or lactating women.
Known hypersensitivity to study medications.
Presence of systemic illness, immunocompromised state, or chronic dermatologic conditions affecting the face.
History of drug induced acne or use of comedogenic cosmetic products.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in acne severity measured by Investigator Global Assessment score |
Baseline, week 4, week 8, week 12, week 16, week 20, week 24, and week 28 |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in inflammatory and non inflammatory lesion counts |
Baseline, week 4, week 8, week 12, week 16, week 20, week 24, and week 28 |
|
|
Target Sample Size
|
Total Sample Size="168"
Sample Size from India="168"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
10/05/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
Randomized, evaluator blinded, parallel group clinical trial aims to compare effectiveness and safety of fixed-dose combination of Adapalene, Benzoyl Peroxide and Clindamycin with Adapalene and Benzoyl Peroxide therapy in patients with mild to moderate acne vulgaris. Participants will be randomly allocated to one of the two treatment groups. Clinical improvement will be assessed using standardized acne severity grading scales at baseline and follow-up visits. |