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

NCT05926869 | Completed Phase 2

• 1 other identifier: NO.F.2-81/2022-GENL/250/JPMC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (1)

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

  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

Study Arms (2)

Group A Clindamycin gel

EXPERIMENTAL

Drug: Clindamycin and Dapsone gel for 03 months

Group B Dapsone gel

EXPERIMENTAL

Drug: Clindamycin and Dapsone gel for 03 months

Interventions

Clindamycin and Dapsone gel for 03 months DRUG

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

Group A Clindamycin gel; Group B Dapsone gel

Eligibility Criteria

• Age: 20 Years - 50 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• moderate acne vulgaris
• either gender
• to 50 yrs

You may not qualify if:

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

Sponsors & Collaborators

• Jinnah Postgraduate Medical Centre: lead

Study Sites (1)

JPMC

Karachi, Sindh, Pakistan

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Clindamycin

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Intervention Hierarchy (Ancestors)

Lincomycin; Lincosamides; Pyrrolidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Glycosides; Carbohydrates

Study Officials

• khadija Asadullah, FCPS

  Jpmc

  PRINCIPAL INVESTIGATOR

• Faiza Inam, FCPS

  Jpmc

  PRINCIPAL INVESTIGATOR

• Nazia Jabeen, FCPS

  JPMC

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: March 22, 2023
• First Posted: July 3, 2023
• Study Start: August 1, 2022
• Primary Completion: December 1, 2022
• Study Completion: February 1, 2023
• Last Updated: July 3, 2023

Record last verified: 2023-06

Locations

PA (1)