| CTRI Number |
CTRI/2017/08/009582 [Registered on: 31/08/2017] Trial Registered Retrospectively |
| Last Modified On: |
14/09/2018 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effectiveness and safety of dapsone 5% versus clindamycin 1% in the treatment of mild to moderate pimples |
|
Scientific Title of Study
|
A randomised, double blind, comparative clinical trial assessing the effectiveness and safety of dapsone 5% versus clindamycin 1% in the treatment of mild to moderate acne vulgaris |
| Trial Acronym |
DCRCT |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Nilay Kanti Das |
| Designation |
Professor |
| Affiliation |
Bankura Sammilani Medical college |
| Address |
Devitala Road Majerpara Ishapore
WEST BENGAL
India
88, college streat, kolkata 700073
North Twentyfour Parganas
WEST BENGAL
743144
India |
| Phone |
9433394148 |
| Fax |
|
| Email |
drdasnilay@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Tushar Kanti Sarkar |
| Designation |
Medical Officer |
| Affiliation |
Paikpari Rural Hospital, Kolaghat |
| Address |
Radha-govinda Nivas greenpark
Barrackpore Sewli Telinipara
North Twentyfour Parganas
WEST BENGAL
700121
India |
| Phone |
9433543508 |
| Fax |
|
| Email |
tks.nrs@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Amrita Sil |
| Designation |
Assistant Professor |
| Affiliation |
IPGMER and SSKM Hospital |
| Address |
S C Rakshit Road Barabazar P O Chandannagar
WEST BENGAL
India
244 AJC Bose Road Kolkata PIN 700020
Kolkata
Hugli
WEST BENGAL
712136
India |
| Phone |
9477737091 |
| Fax |
|
| Email |
drsilamrita@gmail.com |
|
|
Source of Monetary or Material Support
|
| Medical College Kolkata 88 College Street Kolkata 700073 |
|
|
Primary Sponsor
|
| Name |
Medical College Kolkata |
| Address |
88 College Street Kolkata 700073 |
| 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 Nilay Kanti Das |
Medical College hospital |
Dermatology out Patient department 88 college street kolkata 700073
Kolkata
WEST BENGAL
Kolkata
WEST BENGAL |
9433394148
drdasnilay@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FOR HUMAN RESEARCH, MEDICAL COLLEGE, KOLKATA |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
All the patients, aged 12 to 42 years of either sex, presenting with mild to moderate acne(≥ 2 but ≤ 30 total lesions )., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Clindamycin 1% gel |
Patients were instructed to apply thin layer of Clindamycin 1% gel over the lesion twice daily for 12 weeks after rinsing the face and drying |
| Intervention |
Dapsone 5% gel |
Patients were instructed to apply thin layer of dapsone 5% gel over the lesion twice daily for 12 weeks after rinsing the face and drying |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
1.Subjects of 12 to 40 years of age of either sex
2.Mild to moderate acne: ≥ 2 but ≤ 30 total lesions - inflammatory (papules and pustules) and/or non-inflammatory (open and closed comedones)
3.Lesions in the face which correspond to a baseline investigator global assessment (IGA) score of 2 or 3 |
|
| ExclusionCriteria |
| Details |
1.Age <12 or >40
2.Total lesion count < 2 or >30,
3.Subjects regularly using any anti-acne medications in the last 30 days before study entry
4.Severe acne: Subjects with nodulo-cystic lesions, acne conglobata, acne fulminans
5.Pregnancy or intention of pregnancy and breastfeeding
6.Patients with G6PD deficiency
7.History of having taken any medication that could interact with dapsone (e.g. Trimetoprim-sulfametoxazol
8.Known hypersensitivity to the study medication
9.Patients not willing to comply with protocol requirements |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant and Investigator Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
A. To compare the effectiveness of topical dapsone 5% gel and clindamycin 1% gel in the treatment of acne vulgaris.
1.By Global acne assessment scale
2. By no. of acne lesion
3. By size of acne lesion
B. To compare the safety of above mentioned regime
1. By laboratory method
2. By checklist adverse effects |
A. Baseline, end of 4th, 8th and 12th week
B. Baseline and post treatment value |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| •To assess the improvement in quality of life with the two treatment regime |
baseline and end of 12th week |
|
|
Target Sample Size
|
Total Sample Size="56"
Sample Size from India="56"
Final Enrollment numbers achieved (Total)= "51"
Final Enrollment numbers achieved (India)="51" |
|
Phase of Trial
|
Phase 4 |
|
Date of First Enrollment (India)
|
08/10/2015 |
| Date of Study Completion (India) |
27/01/2017 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="4"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
Non Yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Introduction: Acne vulgaris is a common dermatosis of
adolescence having an impact on quality of life and social functioning.
Clindamycin 1% is used for acne because of its activity against Propionibacterium
acnes. Dapsone 5% gel has recently got FDA approval for ACNE management.
Aims and objectives: To
evaluate the effectiveness and safety of Dapsone 5% and Clindamycin 1% in treatment
of mild to moderate acne vulgaris.
Methods: The
institution based randomised control trial was approved by institutional ethics
committee and patients with mild to moderate acne (total lesions ≥ 2 but ≤ 30) were recruited after obtaining informed
consent and were
randomized(balanced un-stratified randomization; allocation ratio1:1;
allocation concealment by SNOSE) into two groups(group A clindamycin; group B dapsone)
respectively and twice daily
topical application was given for a
total duration of 3 months with monthly follow up. Calculated sample size was
56 with 5% alpha error, 80% power and 10% drop-out.
Result: Amongst 51 patients completing the modified
intention-to-treat protocol, 24 received clindamycin 1% (mean age 21.37± 4.65years) and 27 received 5 %
dapsone (mean age 20.96
± 4.73
years). Significant reduction
in acne-global-assessment scale was obtained with both dapsone 5% (Friedman’s
ANOVA P<0.001) and Clindamycin 1%
(Friedman’s ANOVA P=0.001) but the
significant reduction (P<0.05 Post
hoc Dunn’s test) started from 1st follow-up with dapsone5% but from
2nd follow-up with Clindamycin1%. Intergroup comparison of
acne-global-assessment scale showed no significant difference (P>0.05, Mann-Whitney test) at
baseline or any other follow-up visits. Similar result was obtained with number
of inflammatory and non-inflammatory lesions. Quality of life (DLQI) improved
in both treatment arm (P<0.05,
Wilcoxon’s test). Adverse effect (burning, itching, irritation) were
significantly more with Dapsone5% (P value= 0.007, chi square test) at 1st
follow up but became comparable at 2nd and 3rd follow-up
visits.
Conclusions:
Dapsone5% is a promising medication in the treatment of mild-to-moderate acne
vulgaris which shows improvement from 1st month onward, in contrast
to Clindamycin1% where results are seen from 2nd month onward.
Burning, Itching and irritation can occur in the 1st month with
Dapsone1% which resolves later.
Conflict
of Interest: Nil |