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A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris

Primary Purpose

Acne Vulgaris

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Clindamycin and Benzoyl Peroxide Gel 1%5%

BenzaClin® Topical Gel

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 nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts).
Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4
Willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period.
If female of childbearing potential, willing to use an acceptable form of birth control during the study.

Exclusion Criteria

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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy.
Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Active Comparator

Placebo Comparator

Arm Label

Clindamycin/BP Gel 1%5%

BenzaClin® Topical Gel

Placebo

Arm Description

Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks).

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks).

Placebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks).

Outcomes

Primary Outcome Measures

Change in inflammatory lesion count

Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.

Change in non-inflammatory lesion count

Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.

Secondary Outcome Measures

Clinical response of success

The proportion of subjects with a clinical response of success at week 10 (study day 70) defined as an Investigator's Global Assessment score at least 2 grades less than baseline assessment.

Full Information

NCT ID

NCT02595034

First Posted

November 1, 2015

Last Updated

May 3, 2017

Sponsor

Taro Pharmaceuticals USA

1. Study Identification

Unique Protocol Identification Number

NCT02595034

Brief Title

A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris

Official Title

A Randomized Double Blind Multiple Center Placebo Controlled Study Comparing CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® (Clindamycin 1%/Benzoyl Peroxide 5%) Topical Gel in the Treatment of Acne Vulgaris

Study Type

Interventional

2. Study Status

Record Verification Date

May 2017

Overall Recruitment Status

Completed

Study Start Date

January 2015 (undefined)

Primary Completion Date

October 2015 (Actual)

Study Completion Date

November 2015 (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 Clindamycin and Benzoyl Peroxide Gel 1%/5% and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel

Detailed Description

The objectives of this study are to evaluate the therapeutic equivalence and safety of Clindamycin and Benzoyl Peroxide Gel 1%/5% (Taro Pharmaceuticals Inc.) and BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, US) 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

1000 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Clindamycin/BP Gel 1%5%

Arm Type

Experimental

Arm Description

Clindamycin and Benzoyl Peroxide Gel 1%/5% applied twice daily (morning and evening) for 70 days (10 weeks).

Arm Title

BenzaClin® Topical Gel

Arm Type

Active Comparator

Arm Description

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel applied twice daily (morning and evening) for 70 days (10 weeks).

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Placebo (vehicle of the test product) applied twice daily (morning and evening) for 70 days (10 weeks).

Intervention Type

Drug

Intervention Name(s)

Clindamycin and Benzoyl Peroxide Gel 1%5%

Other Intervention Name(s)

Active

Intervention Description

Clindamycin and Benzoyl Peroxide Gel 1%5% (Taro Pharmaceuticals Inc.)

Intervention Type

Drug

Intervention Name(s)

BenzaClin® Topical Gel

Other Intervention Name(s)

Active

Intervention Description

BenzaClin® (clindamycin 1%/benzoyl peroxide 5%) Topical Gel (Sanofi Aventis, U.S.)

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

Change in inflammatory lesion count

Description

Mean percent change from baseline to week 10 (study day 70) in the inflammatory (papules and pustules) lesion counts.

Time Frame

Week 10 (day 70)

Title

Change in non-inflammatory lesion count

Description

Mean percent change from baseline to week 10 (study day 70) in the non-inflammatory (open and closed comedones) lesion counts.

Time Frame

Week 10 (day 70)

Secondary Outcome Measure Information:

Title

Clinical response of success

Description

The proportion of subjects with a clinical response of success at week 10 (study day 70) defined as an Investigator's Global Assessment score at least 2 grades less than baseline assessment.

Time Frame

Week 10 (day 70)

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 nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris. On the face, ≥ 25 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 20 inflammatory lesions (i.e., papules and pustules) AND ≤ 2 nodulocystic lesions (i.e., nodules and cysts). Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4 Willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period. If female of childbearing potential, willing to use an acceptable form of birth control during the study. Exclusion Criteria 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, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis). Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients. Use within 6 months prior to baseline of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed). Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study. Use on the face within 1 month prior to baseline or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy. Use within 1 month prior to baseline of: 1) spironolactone, 2) systemic steroids, 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents. Use within 2 weeks prior to baseline of: 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-the-counter preparations, 4) topical anti-inflammatory agents, 5) medicated cleansers or 6) topical antibiotics.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Catawba Research

Organizational Affiliation

http://catawbaresearch.com/contact/

Official's Role

Study Chair

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

A Study CLBG and Benzoyl Peroxide Gel 1%/5% to BenzaClin® Gel in the Treatment of Acne Vulgaris

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