| CTRI Number |
CTRI/2025/07/091446 [Registered on: 22/07/2025] Trial Registered Prospectively |
| Last Modified On: |
22/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug Other (Specify) [topical treatment ] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing Minocycline Gel with Clindamycin Gel in combination with benzoyl peroxide gel in patients of moderate to severe Acne Vulgaris. |
|
Scientific Title of Study
|
To compare the efficacy and safety of Topical Minocycline 4percent Gel versus Topical Clindamycin 1percent Gel in combination with benzoyl peroxide 2.5percent gel in patients of moderate to severe Acne Vulgaris. A Randomized active controlled open label study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room 117, Department of Dermatology, AIIMS OPD Khandheri, Teh. Paddhari, Dist. Rajkot
Rajkot GUJARAT 360110 India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot
Rajkot GUJARAT 360110 India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Dr Yashdeep Singh Pathania |
| Designation |
Assistant Professor |
| Affiliation |
AIIMS Rajkot |
| Address |
Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot
Rajkot GUJARAT 360110 India |
| Phone |
8894480089 |
| Fax |
|
| Email |
yashdeepsinghpathania@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
All India Institute of Medical Sciences Rajkot |
| Address |
AIIMS,Khandheri, teh Paddhari, Dist Rajkot, Rajkot,Khanderi Rajkot |
| 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 |
| Dr YashdeepSingh Pathania |
All India Institute of Medical Sciences Rajkot |
Room 117, Department of Dermatology, AIIMS OPD,Khandheri, teh Paddhari, Dist Rajkot, Rajkot Rajkot GUJARAT |
8894480089
yashdeepsinghpathania@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Topical Clindamycin 1% Gel |
topical application of clindamycin 1% gel mixed with 1:1 ratio with benzoyl peroxide 2.5% gel will be applied over acne lesions once daily in patients of moderate to severe Acne Vulgaris |
| Intervention |
Topical Minocycline 4% Gel |
topical application of minocycline 4% gel mixed with 1:1 ratio with benzoyl peroxide 2.5% gel will be applied over acne lesions once daily in patients of moderate to severe Acne Vulgaris |
|
|
Inclusion Criteria
|
| Age From |
9.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Male or female individuals age 9 years and above.
Patients having acne vulgaris of moderate-to-severe facial acne, as defined by an Investigator’s Global Assessment (IGA) score of 3 or 4 and lesion counts of 20 to 50 inflammatory lesions (papules, pustules, and nodules), 25 to 100 noninflammatory lesions (open and closed comedone) Providing signed consent forms after understanding the written contents outlining the requirements of participating in the study.
|
|
| ExclusionCriteria |
| Details |
Female subjects who are pregnant, lactating, or planning to become pregnant.
Use of oral retinoids or corticosteroids within 12 weeks
Use of topical retinoids, topical anti-inflammatory drugs and corticosteroids, oral antibiotics, or other systemic acne treatment within 4 weeks
• Patients with concomitant other skin diseases like psoriasis or urticaria.
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. Primary objective
1. The number of patients who achieved IGA-assessed treatment success in each group, i.e IGA score of 0 or 1(description of clear or almost clear) plus at least a 2-grade improvement from baseline.
2. To evaluate the change in absolute count of inflammatory and non-inflammatory lesions from baseline to the end of the study.
|
3 weekly till 12 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
B. Secondary objective
1. To compare the IGA score and absolute inflammatory and non-inflammatory lesions between the two groups A and B in each visit.
2. The safety will be assessed by treatment associated adverse events leading to discontinuation of the treatment.
3. The acne quality of life will be assessed at baseline and week 12 in each group
|
3 weekly till 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="120" Sample Size from India="120"
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 3 |
|
Date of First Enrollment (India)
|
02/08/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
02/08/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2" 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
|
1.
Acne vulgaris is a chronic inflammatory disease of the
pilosebaceous unit characterized by open or closed comedones
(non-inflammatory), papules, pustules, nodules (inflammatory) on the face or
trunk and may result in pain, erythema, hyperpigmentation or scars. It is one
of the most common skin disorders worldwide, with an estimated global
prevalence of 9.38%.1 As per Global burden of diseases study, acne affects
approximately 85% of young adults.2 In India, acne is prevalent in 72.3% of
adolescents and 27% of the adult age group.3Acne can be associated with poor
quality of life leading to depression and anxiety. As per recent International
guidelines, American academy of dermatology limits the use of systemic
antibiotic use when possible to reduce the development of antibiotic resistance
and other systemic side effects related to autoimmune reactions and
gastrointestinal problems.4 The guidelines strongly suggest the use of topical
antibiotics in combination with benzoyl peroxide to prevent development of resistance.
Both topical minocycline and clindamycin are US FDA (Food and Drug
Administration) approved for use in acne. However, there are very few studies
in literature to compare the efficacy of topical antibiotics in moderate to
severe acne vulgaris. Therefore, our study aim will be to compare the efficacy
and safety of topical Minocycline 4% Gel with topical Clindamycin 1% Gel in
combination with benzoyl peroxide 2.5% gel in patients of moderate to severe
Acne Vulgaris.
2.
Hypothesis: Topical minocycline 4% gel
in combination with benzoyl peroxide 2.5% is non inferior to topical
clindamycin 1 % gel with benzoyl peroxide 2.5% in patients of moderate to
severe acne vulgaris.
3. Research questions: Is topical
minocycline 4% gel in combination with benzoyl peroxide 2.5% inot less
efficacious than topical clindamycin 1 % gel with benzoyl peroxide 2.5% in
patients of moderate to severe acne vulgaris? |