| CTRI Number |
CTRI/2025/11/097541 [Registered on: 17/11/2025] Trial Registered Prospectively |
| Last Modified On: |
14/11/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparing the effectiveness and safety of oral zinc, oral doxycycline, and their combination therapy for treating patients with mild to moderate facial acne using benzoyl peroxide as standard treatment. |
|
Scientific Title of Study
|
A comparative study on efficacy and safety of oral zinc vs oral doxycycline vs combined oral zinc and doxycycline in treatment of mild to moderate facial acne vulgaris with topical benzoyl peroxide as common standard therapy - a randomised controlled trial |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Hrishita Vijay Punjabi |
| Designation |
Post Graduate Junior Resident |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
New resident hostel room no 43 gate no 9 opposite emergency MGM medical college and Hospital CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9604325339 |
| Fax |
|
| Email |
punjabihrishita@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashish Deshmukh |
| Designation |
Professor and Head of department |
| Affiliation |
MGM Medical college and Hospital Aurangabad |
| Address |
Department of Dermatology MGM medical college and hospital N6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
9422213292 |
| Fax |
|
| Email |
ashish7557@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashish Deshmukh |
| Designation |
Professor and Head of department |
| Affiliation |
MGM Medical College and Hospital Aurangabad |
| Address |
Department of Dermatology MGM Medical College and Hospital N6 CIDCO
Aurangabad
MAHARASHTRA
431003
India |
| Phone |
94222213292 |
| Fax |
|
| Email |
ashish7557@gmail.com |
|
|
Source of Monetary or Material Support
|
| MGM Medical College and Hospital N6 CIDCO Aurangabad 431003 Maharashtra India |
|
|
Primary Sponsor
|
| Name |
Hrishita Punjabi |
| Address |
New resident hostel room no 43 gate no 9 opposite emergency MGM medical college and Hospital N6 CIDCO Aurangabad 431003 Maharashtra India |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| Hrishita Punjabi |
MGM Medical College and Hospital Aurangabad |
Department of Dermatology 256 MGM hospital Gate no. 2 N-6 cidco
Aurangabad
MAHARASHTRA |
9604325339
punjabihrishita@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| MGM Ethics Committee for Research on Human Subjects |
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 |
administration of Oral Doxycycline 100 mg |
Oral Doxycycline 100 mg capsule once daily for 8 weeks + Topical Benzoyl Peroxide 2.5 % gel once nightly as common standard therapy. |
| Intervention |
administration of Oral Zinc Acetate (50 mg elemental zinc) |
Oral Zinc Acetate (50 mg elemental zinc) once daily for 8 weeks + Topical Benzoyl Peroxide 2.5 % gel once nightly as common standard therapy |
| Comparator Agent |
administration of Oral Zinc Acetate (50 mg elemental zinc) + Oral Doxycycline 100 mg |
Oral Zinc (50 mg elemental zinc) + Oral Doxycycline 100 mg once daily for 8 weeks + Topical Benzoyl Peroxide 2.5 % gel once nightly as common standard therapy.
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Age group 18-35 years
Male or Female patients
Clinically diagnosed with acne vulgaris of grades I , II , III.
More than 10 lesion count
Agreed to sign the consent to be included in the study |
|
| ExclusionCriteria |
| Details |
systemic antibiotics in last 4 weeks , systemic isotretinoin in last 6 months
known allergy to study medications
Additional facial dermatoses (atopic and seborrheic dermatitis)
severe nodulocystic acne
Female Patients who are pregnant and lactating. |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in Global Acne Grading System (GAGS) score from baseline to week 4 and week 8 of treatment |
Baseline, week 4, and week 8. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Change in total lesion counts from baseline to week 4 and week 8. |
Baseline, week 4, and week 8. |
Assessment of side effect profile and adverse drug reactions during treatment.
|
Continuously monitored throughout the 8-week study period.
|
|
|
Target Sample Size
|
Total Sample Size="63"
Sample Size from India="63"
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)
|
25/11/2025 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| 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
|
It is a randomized, parallel group, active controlled, interventional clinical trial To compare the efficacy and safety of oral zinc, oral doxycycline, and their combination, each given along with topical benzoyl peroxide 2.5 percent gel as standard therapy, in patients with mild to moderate facial acne vulgaris.
Eligible participants will be randomized into three groups to receive either oral zinc acetate 50 mg elemental zinc once daily , oral doxycycline 100 mg once daily, or oral zinc 50 mg plus oral doxycycline 100 mg once daily, for a period of eight weeks. To assess the efficacy of oral zinc in treatment of mild to moderate acne vulagris To assess the efficacy of oral doxycycline in treatment of mild to moderate acne vulagris To investigate whether a combination therapy of zinc and doxycycline provide superior clinical outcome compared to monotherapy. To study the side effects profiles among three groups.
|