| CTRI Number |
CTRI/2024/06/069345 [Registered on: 21/06/2024] Trial Registered Prospectively |
| Last Modified On: |
20/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Comparison between tazarotene 0.05 percent gel and adapalene 0.1 percent gel in acne patients. |
|
Scientific Title of Study
|
Efficacy of Tazarotene 0.05 percent gel vs Adapalene 0.1 percent gel in treatment of acne vulgaris A randomised case controlled trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sharwari Jaiswal |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venerology and Leprosy,
1st floor, DMIHER, Sawangi, Wardha
Maharashtra
442001
India
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096446172 |
| Fax |
|
| Email |
sharwarijaiswal@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr. Sugat Jawade |
| Designation |
Professor |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venerology and Leprosy
1st floor, DMIHER ,Sawangi, Wardha
MAHARASHTRA
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096446172 |
| Fax |
|
| Email |
drsugat09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Sharwari Jaiswal |
| Designation |
Junior Resident |
| Affiliation |
Datta Meghe Institute of Higher Education and Research |
| Address |
Department of Dermatology, Venerology and Leprosy,
1st floor , DMIHER , Sawangi , Wardha
MAHARASHTRA
442001
Wardha
MAHARASHTRA
442001
India |
| Phone |
9096446172 |
| Fax |
|
| Email |
sharwarijaiswal@gmail.com |
|
|
Source of Monetary or Material Support
|
| Acharya vinoba bhave rural hospital, wardha Maharashtra , India
pin code - 442001 |
|
|
Primary Sponsor
|
| Name |
Dr Sharwari Jaiswal |
| Address |
Department of Dermatology, Venerology and Leprosy,
1st floor, DMIHER, Sawangi, Wardha
MAHARASHTRA
442001 |
| 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 |
| Dr Sharwari jaiswal |
Acharya Vinoba Bhave Rural Hospital, Sawangi |
Department of Dermatology, venereology and leprosy, 1st floor DMIHER,Sawangi, Wardha, Maharashtra, India 442001
Wardha
MAHARASHTRA |
9096446172
sharwarijaiswal@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Datta meghe institute of medical sciences, Institutional 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 |
| Comparator Agent |
Adapelene |
Dose- 0.1% gel
ROA- topical
Frequency- once a day
Duration of Treatment - 12 weeks |
| Intervention |
Tazarotene |
Tazarotene
Dose- 0.05% gel
ROA- topical
Frequency- once a day
Duration of Treatment - 12 weeks |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
1) Patients irrespective of gender.
2) Patients with age >12 – 35 years.
3) Patients willing to participate.
4) Patients with acne grade: I, II, III.
|
|
| ExclusionCriteria |
| Details |
1. History of hypersensitivity or allergic reaction to retinoids
2. Patients with a history of photosensitivity.
3. Females who are pregnant, lactating mothers and married women planning for pregnancy.
4. Patient with photo aggravated disorders.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To observe the improvement in the acne of patients based on Global acne scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, and the side effects that arise with the usage of 0.05% tazarotene and 0.1% adapalene. |
1 year 2 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| treatment wherein oral medication need not be given or are contraindicated. |
8 weeks |
| Total clearance of lesions, improvement in numbers of counts of comedones, papules, pustules, & nodules, improvement in global acne scoring, side effects i.e. dryness, erythema, itching, & flare-up of acne will be studied. To observe the improvement in the acne of patients based on Global acne scoring systems, keeping a note of the decrease in the number of counts of lesions with every follow-up visit or clearance of lesions, subjective patient improvement scoring, & the side effects that arise with the usage of 0.05% tazarotene & 0.1% adapalene. |
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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/ Phase 4 |
|
Date of First Enrollment (India)
|
17/07/2024 |
| 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="2"
Days="2" |
|
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
|
Acne is an extremely common skin condition, which has a major social and psychological impact on young patients [3]. Retinoids have been a mainstay of anti-acne therapy. Older generation agents are slowly replaced by newer generation ones like tazarotene and adapalene as they exhibit lower toxicologic risk and less side effects and they effectively reduce the comedones and inflammatory lesions. Unlike Tretinoin, these are newer agents are specific for a subset of retinoic acid receptors exhibiting lower toxicologic risk and producing fewer side effects.This study tthrows light on effectiveness of topical Adapalene gel- 0.1% and Tazarotene gel-0.05% in order to find out a suitable option with lesser side effects for acne patients. |