To compare the outcome of treatment of topical 5% dapsone versus topical 1% clindamycin in treatment of mild to moderate acne vulgaris at Allama Iqbal Memorial Teaching Hospital, Sialkot, Pakistan.
Design
Randomized Controlled Trial
Settings and conduct
Department Of Dermatology, Allama Iqbal Memorial Teaching Hospital, Sialkot, Pakistan
Participants/Inclusion and exclusion criteria
Inclusion Criteria:
Patients of either gender, between 18-60 years of age, presenting with mild to moderate acne vulgaris as per operational definition will be included in the study.
Exclusion Criteria:
Pregnant patients and Lactating mothers.
Patients do not take any oral antibiotics for 4 weeks and topical antibiotics for 2 weeks.
Patients have other facial conditions besides acne vulgaris (e.g., rosacea).
Patients taking Glucocorticoids, Phenytoin, Isoniazid and Lithium
Patients with history of allergy with the study medication
Intervention groups
Patients with Mild to Moderate Acne Vulgaris as per the Global Acne Grading System will be randomly allocated using sealed opaque envelops bearing A= Clindamycin 1% gel group and B= Dapsone 5% gel group. Dapsone gel topically will be applied at bedtime on the lesions daily for 12 weeks. While clindamycin 1% gel treatment will be applied twice daily for 12 weeks. The outcome of both treatments will be assessed after 12 weeks of treatment in term of Mean GAGS score
Main outcome variables
The outcome will be assessed in terms of the mean Global Acne Grading System scores after the 12-week treatment period, defined as follows:
1. Mean GAGS Scores:
The primary outcome will be the mean GAGS scores in dapsone 5% group and the clindamycin 1% group at the end of the 12-week treatment period.
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20250124064503N1
Registration date:2025-02-03, 1403/11/15
Registration timing:registered_while_recruiting
Last update:2025-02-03, 1403/11/15
Update count:0
Registration date
2025-02-03, 1403/11/15
Registrant information
Name
Muhammad Bilal Iftikhar
Name of organization / entity
Khawaja Muhammad Safdar Medical College
Country
Pakistan
Phone
+92 48 3256011
Email address
bilaliftikhar28@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2025-02-03, 1403/11/15
Expected recruitment end date
2025-05-03, 1404/02/13
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
OUTCOME OF TOPICAL DAPSONE 5% VERSUS TOPICAL CLINDAMYCIN 1% IN TREATMENT OF MILD TO MODERATE ACNE VULGARIS
Public title
To Compare Efficacy and safety of Topical Dapsone 5% versus Topical Clindamycin 1% In Treatment of Mild to Moderate Acne Vulgaris
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Both Males and Females
18-60 Years of age
Mild to Moderate Acne Vulgaris as per Global Acne Grading Score
Exclusion criteria:
Pregnant patients and Lactating mothers
Patients do not take any oral antibiotics for 4 weeks and topical antibiotics for 2 weeks
Patients have other facial conditions besides acne vulgaris (e.g.' ,rosacea)
Patients taking Glucocorticoids, Phenytoin, Isoniazid and Lithium
Patients with history of allergy with the study medication
Age
From 18 years old to 60 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
132
Randomization (investigator's opinion)
Randomized
Randomization description
A brief history of demographic information and written informed consent will be taken from each patient. Patients will be examined by dermatologists and will be graded. Patients will be randomly allocated using sealed opaque envelops bearing A= Clindamycin 1% gel group and B= Dapsone 5% gel group. Dapsone gel topically will be applied at bedtime on the lesions daily for 12 weeks. While clindamycin 1% gel treatment will be applied twice daily for 12 weeks. The outcome of both treatments will be assessed in 12 weeks of treatment .
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Research Ethics Committee, Khawaja Muhammad Safdar Medical College, Sialkot
Street address
Khawaja Muhammad Safdar Medical College, Sialkot
City
Sialkot
Postal code
51310
Approval date
2024-12-31, 1403/10/11
Ethics committee reference number
No:47/REC/KMSMC
Health conditions studied
1
Description of health condition studied
Acne Vulgaris
ICD-10 code
L70.0
ICD-10 code description
Acne vulgaris
Primary outcomes
1
Description
The Primary Outcome will be the mean Global Acne Grading System Score in Dapsone 5% group and the Clindamycin 1% group at the end of 12 weeks treatment period
Timepoint
12 weeks
Method of measurement
Global Acne Grading System Score
Secondary outcomes
1
Description
Other Variables like Irritation, Burning Sensation, Pruritis, Erythema and oily skin after use of the Topical Drugs
Timepoint
12 weeks
Method of measurement
Question will be asked regarding above mentioned side effects
Intervention groups
1
Description
Intervention group 1: Dapsone 5% Gel
Category
Treatment - Drugs
2
Description
Intervention group 2: Clindamycin 1%
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Khawaja Muhammad Safdar Medical College/Allama Iqbal Memorial Teaching Hospital, Sialkot
Full name of responsible person
Dr Bushra Bashir ( Head Of Department of Dermatology KMSMC/AIMTH, Sialkot)
Street address
Khawaja Muhammad Safdar Medical College, Sialkot
City
Sialkot
Postal code
51310
Phone
+92 52 9250738
Email
info@kmsmc.edu.pk
Web page address
https://kmsmc.edu.pk
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Khawaja Muhammad Safdar Medical College/Allama Iqbal Memorial Teaching Hospital, Pakistan
Full name of responsible person
Dr Zareen Saqib( Assistant Professor of Dermatology)
Street address
Dermatology Demartment, Khawaja Muhammad Safdar Medical College
City
Sialkot
Postal code
51310
Phone
+92 336 4220553
Email
dr.zarex@gmail.com
Web page address
https://kmsmc.edu.pk/
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Khawaja Muhammad Safdar Medical College/Allama Iqbal Memorial Teaching Hospital, Pakistan
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Khawaja Muhammad Safdar Medical College
Full name of responsible person
Muhammad Bilal Iftikhar
Position
Post Graduate Resident, Dermatology
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
bilaliftikhar28@gmail.com
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 48 3256011
Email
bilaliftikhar28@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Khawaja Muhammad Safdar Medical College
Full name of responsible person
Muhammad Bilal Iftikhar
Position
Post Graduate Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Khawaja Muhammad Safdar Medical College, Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 48 3256011
Fax
Email
bilaliftikhar28@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Khawaja Muhammad Safdar Medical College
Full name of responsible person
Muhammad Bilal Iftikhar
Position
Post Graduate Resident
Latest degree
Medical doctor
Other areas of specialty/work
Dermatology
Street address
Dermatology Department, Khawaja Muhammad Safdar Medical College, Sialkot
City
Sialkot
Province
Punjab
Postal code
51310
Phone
+92 48 3256011
Fax
Email
bilaliftikhar28@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available