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CompletedNCT02595034Updated May 4, 2017

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

A Phase 1 interventional study of Clindamycin and Benzoyl Peroxide Gel 1%5% and BenzaClin® Topical Gel in Acne Vulgaris, sponsored by Taro Pharmaceuticals USA. Completed. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2017-05-04.

Sponsored by Taro Pharmaceuticals USA · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
1,000
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study 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

Read the 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

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Conditions studied

  • Acne Vulgaris

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03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 85 are open to participants now.

This study's enrollment of 1,000 is above the median of 68 across 627 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Taro Pharmaceuticals USA is the lead sponsor of 71 studies on the registry; none are open to participants now.

Of its 19 completed or terminated interventional studies of FDA-regulated products, 1 (5%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
12 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  1. Healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
  2. 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).
  3. Investigator's Global Assessment (IGA) of acne severity grade 2, 3, or 4
  4. Willing to refrain from use of all other topical acne medications or antibiotics during the 10week treatment period.
  5. If female of childbearing potential, willing to use an acceptable form of birth control during the study.

Exclusion criteria

Exclusion Criteria

  1. 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).
  2. Excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
  3. History of hypersensitivity or allergy to benzoyl peroxide or clindamycin and/or any of the study medication ingredients.
  4. 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).
  5. Use for less than 3 months prior to baseline of estrogens or oral contraceptives; use of such therapy must remain constant throughout the study.
  6. 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.
  7. 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.
  8. 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.
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
1,000 participants (actual)

Study arms

  • Experimental
    Clindamycin/BP Gel 1%5%

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

    Drug: Clindamycin and Benzoyl Peroxide Gel 1%5%

  • Active comparator
    BenzaClin® Topical Gel

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

    Drug: BenzaClin® Topical Gel

  • Placebo comparator
    Placebo

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

    Drug: Placebo

Interventions

  • DrugClindamycin and Benzoyl Peroxide Gel 1%5%

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

    Also known as: Active

  • DrugBenzaClin® Topical Gel

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

    Also known as: Active

  • DrugPlacebo

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

    Also known as: Vehicle

06

What researchers measure

Primary outcomes

  1. Change in inflammatory lesion count

    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)

  2. 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.

    Time frame: Week 10 (day 70)

Secondary outcomes

  1. 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.

    Time frame: Week 10 (day 70)

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Study locations

No study locations are listed for this record.

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References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT02595034
Lead sponsor
Taro Pharmaceuticals USA
Responsible party
Sponsor
First posted
Nov 3, 2015
Start date
Jan 2015
Primary completion
Oct 2015
Completion
Nov 2015
Last update
May 4, 2017

Study contacts

Catawba Research
study chair · http://catawbaresearch.com/contact/

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.

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