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

Sponsor

Jinnah Postgraduate Medical Centre (Other)

Overall Status

Completed

CT.gov ID

NCT05926869

Collaborator

(none)

100

Enrollment

Location

Arms

Actual Duration (Months)

16.5

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Clindamycin and Dapsone gel for 03 months	Phase 2

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 Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Actual Study Start Date :

Aug 1, 2022

Actual Primary Completion Date :

Dec 1, 2022

Actual Study Completion Date :

Feb 1, 2023

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

20 Years to 50 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

Inclusion Criteria:

moderate acne vulgaris
either gender
20 to 50 yrs

Exclusion Criteria:

systemic treatment taken
pregnant or lactating women
hematological abnormalities

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	JPMC	Karachi	Sindh	Pakistan

Sponsors and Collaborators

Jinnah Postgraduate Medical Centre

Investigators

Principal Investigator: khadija Asadullah, FCPS, Jpmc
Principal Investigator: Faiza Inam, FCPS, Jpmc
Principal Investigator: Nazia Jabeen, FCPS, JPMC

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr. Parisa Sanawar, Principal Investigator, Jinnah Postgraduate Medical Centre

ClinicalTrials.gov Identifier:

NCT05926869

Other Study ID Numbers:

NO.F.2-81/2022-GENL/250/JPMC

First Posted:

Jul 3, 2023

Last Update Posted:

Jul 3, 2023

Last Verified:

Jun 1, 2023

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Acne Vulgaris

Clindamycin

Clindamycin palmitate

Clindamycin phosphate

Dapsone

Study Results

No Results Posted as of Jul 3, 2023