Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris

June 23, 2023 updated by: Dr. Parisa Sanawar, Jinnah Postgraduate Medical Centre
Acne vulgaris (AV) is a disease of the pilosebaceous unit that causes noninflammatory lesions (open and closed comedones), inflammatory lesions (papules, pustules, and nodules), and varying degrees of scarring. The key pathogenic processes includes alteration of follicular keratinization that leads to comedones; increased and altered sebum production under androgen control; follicular colonization by Propionibacterium acnes; . The role of topical antibiotics in treating acne is well established. Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. The extensive use of antibiotics in acne has lead to the development of resistance to antimicrobial therapy. Dapsone is known to have antibacterial as well as anti-inflammatory action which may help in reduction of acne.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris.

Study Type

Interventional

Enrollment (Actual)

100

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Sindh
      • Karachi, Sindh, Pakistan
        • JPMC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • moderate acne vulgaris
  • either gender
  • 20 to 50 yrs

Exclusion Criteria:

  • systemic treatment taken
  • pregnant or lactating women
  • hematological abnormalities

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group A Clindamycin gel
Drug: Clindamycin and Dapsone gel for 03 months
Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris. It has antibacterial as well as anti inflammatory effects
Experimental: Group B Dapsone gel
Drug: Clindamycin and Dapsone gel for 03 months
Clindamycin is a topical antibiotic which has been widely used in treatment of acne for many decades. Topical Dapsone 5% gel contains sulfone and has an advanced solvent micro particulate delivery system that enables penetration of stratum corneum . It is a new topical drug used in the treatment of Moderate Acne Vulgaris. It has antibacterial as well as anti inflammatory effects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of the Efficacy of Clindamycin Phosphate 1% Gel Versus Once-daily Dapsone 5% Gel in the Treatment of Moderate Acne Vulgaris
Time Frame: It will be assessed upto 03 months
Efficacy will be assessed using Global Acne Grading Sore ( GAGS ). For GAGS (Score 1-18 = mild, score 19-30 = moderate, score 31-38 = severe). Mean difference of GAGs score before and after the treatment will be calculated.
It will be assessed upto 03 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jinnah Postgraduate Medical Centre

Investigators

  • Principal Investigator: Nazia Jabeen, FCPS, JPMC
  • Principal Investigator: KHADIJA ASADULLAH, FCPS, JPMC
  • Principal Investigator: FAIZA INAM, FCPS, JPMC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

August 1, 2022

Primary Completion (Actual)

December 1, 2022

Study Completion (Actual)

February 1, 2023

Study Registration Dates

First Submitted

March 22, 2023

First Submitted That Met QC Criteria

June 23, 2023

First Posted (Actual)

July 3, 2023

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 23, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • NO.F.2-81/2022-GENL/250/JPMC

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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