| CTRI Number |
CTRI/2023/11/060308 [Registered on: 29/11/2023] Trial Registered Prospectively |
| Last Modified On: |
25/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of topical tretinoin versus topical tazarotene in acne vulgaris. |
|
Scientific Title of Study
|
Comparative efficacy of different concentration of topical tazarotene and topical tretinoin in acne vulgaris. |
| 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 Sunidhi Sharma |
| Designation |
Post Graduate Junior resident |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9876879796 |
| Fax |
|
| Email |
sunidhisharma138@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Professor G P Thami |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121544 |
| Fax |
9646121544 |
| Email |
thamigp@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Professor G P Thami |
| Designation |
Professor and Head |
| Affiliation |
Government Medical College and Hospital, Chandigarh |
| Address |
Department Of Dermatology,5th floor, D block, Government Medical College and Hospital, Sector 32 B, Chandigarh
Chandigarh
CHANDIGARH
160030
India |
| Phone |
9646121544 |
| Fax |
9646121544 |
| Email |
thamigp@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Medical College and Hospital Chandigarh |
|
|
Primary Sponsor
|
| Name |
Department of Dermatology |
| Address |
Government Medical College and Hospital,sector 32B, Chandigarh, 160030 |
| Type of Sponsor |
Government medical college |
|
|
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 Sunidhi Sharma |
Government Medical College and Hospital Chandigarh |
Dermatology Venereology and leprosy OPD 4th floor B block Government Medical College and Hospital Sector 32B Chandigarh 160030
Chandigarh
CHANDIGARH |
9876879796
sunidhisharma138@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Insitutional Ethics Committee |
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 |
| Intervention |
Topical tazarotene 0.05% |
20 patients will be given topical tazarotene 0.05% OD at night for a period of 8 weeks, with evaluation at every 2 weeks. |
| Intervention |
Topical tazarotene 0.1% |
20 patients will be given topical tazarotene 0.1% OD at night for a period of 8 weeks, with evaluation every 2 weeks. |
| Comparator Agent |
Topical tretinoin 0.025% |
20 patients will be given topical tretinoin 0.025% OD at night for a period of 8 weeks, with evaluation at every 2 weeks. |
| Comparator Agent |
Topical tretinoin 0.05% |
20 patients will be given topical tretinoin 0.05% OD at night for a period of 8 weeks, with evaluation at every 2 weeks. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients of acne vulgaris (Grade 1 & 2) involving face and not requiring systemic therapy.
2. Patients of 18-50 years of age. |
|
| ExclusionCriteria |
| Details |
1. Pregnant and lactating mothers
2. Patients having any systemic illness requiring drugs
3. Patients with signs and symptoms of hyperandrogenism
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. To compare the clinical efficacy of topical 0.025% and 0.05% tretinoin with 0.05% and 0.1% tazarotene in acne vulgaris.
|
2nd, 4th, 6th and 8th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| 2. To assess and compare the adverse effects of these therapeutic agents. |
2nd, 4th, 6th and 8th week |
|
|
Target Sample Size
|
Total Sample Size="80"
Sample Size from India="80"
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
|
N/A |
|
Date of First Enrollment (India)
|
05/12/2023 |
| 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="0"
Months="5"
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
|
Various studies have been conducted in past comparing different topical agents belonging to different groups for acne vulgaris. Despite this, there is lack of data comparing efficacy of different concentration of topical retinoids. This study aims at comparing the clinical efficacy of topical 0.025% and 0.05% tretinoin with 0.05% and 0.1% tazarotene in acne vulgaris as there are no studies in literature comparing the efficacy of these four topical retinoids with each other. |