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

NCT ID: NCT05926869

Last Updated: 2023-07-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

100 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-08-01

Study Completion Date

2023-02-01

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Acne Vulgaris

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Group A Clindamycin gel

Group Type EXPERIMENTAL

Clindamycin and Dapsone gel for 03 months

Intervention Type 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 B Dapsone gel

Group Type EXPERIMENTAL

Clindamycin and Dapsone gel for 03 months

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* systemic treatment taken
* pregnant or lactating women
* hematological abnormalities
Minimum Eligible Age

20 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Jinnah Postgraduate Medical Centre

OTHER_GOV

Sponsor Role lead

Responsible Party

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Dr. Parisa Sanawar

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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khadija Asadullah, FCPS

Role: PRINCIPAL_INVESTIGATOR

Jpmc

Faiza Inam, FCPS

Role: PRINCIPAL_INVESTIGATOR

Jpmc

Nazia Jabeen, FCPS

Role: PRINCIPAL_INVESTIGATOR

JPMC

Locations

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JPMC

Karachi, Sindh, Pakistan

Site Status

Countries

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Pakistan

Other Identifiers

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

Identifier Type: -

Identifier Source: org_study_id

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