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Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 1

Locations

United States

Study Type

Interventional

Intervention

CLPG Topical Gel 1%

Clindamycin

Placebo

About this trial

This is an interventional treatment trial for Acne Vulgaris

Eligibility Criteria

12 Years - 40 Years (Child, Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris
Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian).
Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA).

Exclusion Criteria:

Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs.
Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Sites / Locations

Catawba Research, LLC

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

CLPG Topical Gel 1%

Clindamycin Phosphate Topical Gel 1%

Vehicle of the test product

Arm Description

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Placebo (vehicle of the test product), applied to the face twice a day for 84 days.

Outcomes

Primary Outcome Measures

Demonstration of Bioequivalence

Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.

Secondary Outcome Measures

Full Information

NCT ID

NCT04134273

First Posted

October 18, 2019

Last Updated

October 18, 2019

Sponsor

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT04134273

Brief Title

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

Official Title

A Randomized, Double-Blind, Multiple Center Placebo Controlled Study Comparing Taro Product to RLD and Both Treatments to a Placebo Control in the Treatment of Acne Vulgaris.

Study Type

Interventional

2. Study Status

Record Verification Date

October 2019

Overall Recruitment Status

Completed

Study Start Date

March 20, 2019 (Actual)

Primary Completion Date

September 17, 2019 (Actual)

Study Completion Date

October 15, 2019 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Taro Pharmaceuticals USA

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

5. Study Description

Brief Summary

This study is to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris.

Detailed Description

The study objectives are to evaluate the therapeutic equivalence and safety of Taro Product to RLD in the treatment of acne vulgaris and to demonstrate the superiority of the efficacy of the test and reference products over the placebo control.

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 1

Interventional Study Model

Parallel Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

1260 (Actual)

8. Arms, Groups, and Interventions

Arm Title

CLPG Topical Gel 1%

Arm Type

Experimental

Arm Description

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Arm Title

Clindamycin Phosphate Topical Gel 1%

Arm Type

Active Comparator

Arm Description

Clindamycin Phosphate Topical Gel 1%, applied to the face twice a day for 84 days.

Arm Title

Vehicle of the test product

Arm Type

Placebo Comparator

Arm Description

Placebo (vehicle of the test product), applied to the face twice a day for 84 days.

Intervention Type

Drug

Intervention Name(s)

CLPG Topical Gel 1%

Other Intervention Name(s)

Topical Gel 1%

Intervention Description

Clindamycin Phosphate Topical Gel 1% (Taro Pharmaceuticals U.S.A, Inc.)

Intervention Type

Drug

Intervention Name(s)

Clindamycin

Other Intervention Name(s)

Topical Gel 1%

Intervention Description

Clindamycin Phosphate topical gel 1%

Intervention Type

Drug

Intervention Name(s)

Placebo

Other Intervention Name(s)

Vehicle

Intervention Description

Placebo (vehicle of the test product) (Taro Pharmaceuticals Inc.)

Primary Outcome Measure Information:

Title

Demonstration of Bioequivalence

Description

Demonstration of Bioequivalence in percent change in inflammatory and non-inflammatory lesion counts.

Time Frame

Week 12

10. Eligibility

Sex

All

Minimum Age & Unit of Time

12 Years

Maximum Age & Unit of Time

40 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris Subjects who are 18 years of age or older (up to the age of 40) must have provided IRB approved written informed consent. Subjects 12 to 17 years of age, inclusive, must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). Subjects must have a definite clinical diagnosis of acne vulgaris severity grade 2, 3, or 4 as per the Investigator's Global Assessment (IGA). Exclusion Criteria: Female Subjects who are pregnant, nursing or planning to become pregnant during study participation. Subjects with a known hypersensitivity to clindamycin or lincomycin and/or any ingredients in the study drugs. Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).

Facility Information:

Facility Name

Catawba Research, LLC

City

Charlotte

State/Province

North Carolina

ZIP/Postal Code

28217

Country

United States

12. IPD Sharing Statement

Learn more about this trial

Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris

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