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

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 2

Locations

Pakistan

Study Type

Interventional

Intervention

Clindamycin and Dapsone gel for 03 months

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

20 Years - 50 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: moderate acne vulgaris either gender 20 to 50 yrs Exclusion Criteria: systemic treatment taken pregnant or lactating women hematological abnormalities

Sites / Locations

JPMC

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

Group A Clindamycin gel

Group B Dapsone gel

Arm Description

Outcomes

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

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.

Secondary Outcome Measures

Full Information

NCT ID

NCT05926869

First Posted

March 22, 2023

Last Updated

June 23, 2023

Sponsor

Jinnah Postgraduate Medical Centre

1. Study Identification

Unique Protocol Identification Number

NCT05926869

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2023

Overall Recruitment Status

Completed

Study Start Date

August 1, 2022 (Actual)

Primary Completion Date

December 1, 2022 (Actual)

Study Completion Date

February 1, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Jinnah Postgraduate Medical Centre

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

5. 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.

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acne Vulgaris

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

100 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Group A Clindamycin gel

Arm Type

Experimental

Arm Title

Group B Dapsone gel

Arm Type

Experimental

Intervention Type

Drug

Intervention Name(s)

Clindamycin and Dapsone gel for 03 months

Intervention Description

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

Primary Outcome Measure Information:

Title

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

Description

Time Frame

It will be assessed upto 03 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

50 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: moderate acne vulgaris either gender 20 to 50 yrs Exclusion Criteria: systemic treatment taken pregnant or lactating women hematological abnormalities

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

khadija Asadullah, FCPS

Organizational Affiliation

Jpmc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Faiza Inam, FCPS

Organizational Affiliation

Jpmc

Official's Role

Principal Investigator

First Name & Middle Initial & Last Name & Degree

Nazia Jabeen, FCPS

Organizational Affiliation

JPMC

Official's Role

Principal Investigator

Facility Information:

Facility Name

JPMC

City

Karachi

State/Province

Sindh

Country

Pakistan

12. IPD Sharing Statement

Learn more about this trial

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

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