| CTRI Number |
CTRI/2023/11/059725 [Registered on: 09/11/2023] Trial Registered Prospectively |
| Last Modified On: |
08/11/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
To compare different drugs like dapsone and clindamycin in patients of Acne Vulgaris over face. |
|
Scientific Title of Study
|
A COMPARATIVE STUDY OF EFFICACY AND SAFETY OF TOPICAL CLINDAMYCIN 1% GEL VERSUS TOPICAL DAPSONE 5% GEL IN ACNE VULGARIS OVER FACE: A PROSPECTIVE RANDOMIZED DOUBLE BLIND 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 Jyoti Gadhvi |
| Designation |
Post Graduate Student |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9998465636 |
| Fax |
|
| Email |
jyotigadhvi1997@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Devendra Singh Kushwah |
| Designation |
Professor |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
8889925777 |
| Fax |
|
| Email |
dev_singh433@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Jyoti Gadhvi |
| Designation |
Post Graduate Student |
| Affiliation |
Gajra Raja Medical College |
| Address |
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Department of Pharmacology, Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh
Gwalior
MADHYA PRADESH
474009
India |
| Phone |
9998465636 |
| Fax |
|
| Email |
jyotigadhvi1997@gmail.com |
|
|
Source of Monetary or Material Support
|
| Gajra Raja Medical College, Vir Savarkar Marg, Gwalior, Madhya Pradesh |
|
|
Primary Sponsor
|
| Name |
Dr Jyoti Gadhvi |
| Address |
Department of Pharmacology, Gajra Raja Medical College, Gwalior, Madhya Pradesh |
| 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 Jyoti Gadhvi |
Jaya Arogya group of Hospital, Gajra Raja Medical College |
Department of Dermatology, C Block.
Gwalior
MADHYA PRADESH |
9998465636
jyotigadhvi1997@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, Gajra Raja Medical College |
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 |
Clindamycin 1% gel |
Clindamycin 1% gel topical application for patients of Acne Vulgaris once daily for 3 months |
| Intervention |
Dapsone 5% Gel |
Dapsone 5% Gel has a topical application for the patients of Acne Vulgaris once daily for 3 months |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients having ISGA scoring of 1 or more at baseline.
Patients who are willing to take part in the study with signed and written informed consent.
Patients could be of both male and female.
All patients who are 15-45 years of age
Patient must be medically stable.
Patient must have active mobile number.
|
|
| ExclusionCriteria |
| Details |
Pregnant, breast feeding, child bearing age using contraception.
Patient with nodulocystic lesions (ISGA Grade 4 and ISGA Grade 5) at the baseline.
Patient with a K/C/O any Autoimmune conditions like SLE, Thyroid disorder, Vitiligo, etc.
Patient receiving systemic treatment relevant to Facial Acne Vulgaris within 3 months of enrollment.
Patient receiving Topical treatment relevant to Facial Acne within 1 months
Patient who are on medications like topical facial antibiotics, topical acne medicines, topical corticosteroids within 2 weeks.
Patients who have undergone any facial procedures within 1 months.
Patients using any systemic retinoids or received treatment with estrogens or anti-androgenic agents within 2 months.
|
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the efficacy of Test Drugs on lesion count in the patients of Acne Vulgaris over face.
To compare the efficacy between both the groups.
To evaluate and compare the safety profile between the test drugs in patients of Acne Vulgaris over face.
|
1st visit At baseline
2nd visit at 4th week
3rd visit at 8th week
4th visit at 12th week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate the impact of Acne Vulgaris on quality of life of patients |
1st visit At baseline
2nd visit at 4th week
3rd visit at 8th week
4th visit at 12th 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
|
Phase 3/ Phase 4 |
|
Date of First Enrollment (India)
|
20/11/2023 |
| 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="1"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
- Who will be able to view these files?
Response - Researchers whose proposed use of the data has been approved by an independent review committee identified for this purpose.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [jyotigadhvi1997@gmail.com].
- For how long will this data be available start date provided 07-11-2023 and end date provided 07-11-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
As there is a known
resistance to certain antibiotics, such as macrolides and quinolones, used to
treat acne, and a handful adverse effects are associated to other systemic
therapies, like retinoids, and many people prefer topical treatments to
systemic ones, the best topical therapy is sought after. We therefore,
considered comparing the efficacy of 5% dapsone gel with a proven therapy
option, such as 1% clindamycin gel. This study is an interventional, double blind, prospective, randomized and comparative study. There are 2 groups : Clindamycin 1% gel group and Dapsone 5% gel group. Both these drugs are compared for their efficacy in Acne Vulgaris over face. At baseline visit, Total lesion count and ISGA score of the patient will be noted and patients will be randomized for their distribution in either of the given groups. 2nd visit will be at 4 weeks, 3rd visit will be at 8 weeks and 4th visit will be at 12 weeks. The primary purpose is to study the efficacy of both drugs for acne vulgaris over face by observing the changes in their ISGA score and Total Lesion Count, to
compare the efficacy between
both the groups, to
evaluate and compare the safety profile between the test drugs in patients of Acne
Vulgaris over face. The secondary objective is to evaluate the impact of Acne
Vulgaris on quality of life of patients.
Hypothesis : By
this comparative study,
in our institute we will find out whether
either one of the test drug is more efficacious and safer than the other or
not. |