Bioequivalence Study of Clindamycin Gel 1% in Treatment of Acne Vulgaris

A

Akorn

Status and phase

Completed
Phase 3

Conditions

Acne Vulgaris

Treatments

Drug: Clindamycin 1% Gel
Drug: Placebo

Study type

Interventional

Funder types

Industry

Identifiers

NCT03522441
CLMG 1711

Details and patient eligibility

About

This is a randomized, double-blind, multiple-site, placebo-controlled, parallel-group study, designed to compare the efficacy and safety of generic Clindamycin 1% gel (Akorn), and the marketed product Clindamycin 1% gel (Greenstone LLC) in the treatment of acne vulgaris.

Enrollment

1,125 patients

Sex

All

Ages

12 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

IInclusion Criteria:

  • Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
  • Have facial acne with: ≥20 facial inflammatory lesions (papules and pustules) and ≥25 non-inflammatory lesions (open and closed comedones), and ≤2 nodulocystic lesions (nodules and cysts) and have an IGA score of 2, 3 or 4.

Exclusion Criteria:

  • Subject has more than 2 facial nodular lesions; any nodules present will be documented but not included in the inflammatory lesion count for analysis.
  • Subject has active cystic acne.
  • Subject has acne conglobata.
  • Subjects with excessive facial hair such as beards, sideburns, moustaches, etc. that would interfere with the diagnosis or assessment of acne.

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

1,125 participants in 3 patient groups, including a placebo group

Clindamycin 1% gel (Akorn Pharmaceuticals)
Experimental group
Treatment:
Drug: Clindamycin 1% Gel
Clindamycin 1% gel (Greenstone LLC)
Active Comparator group
Treatment:
Drug: Clindamycin 1% Gel
Placebo
Placebo Comparator group
Treatment:
Drug: Placebo

Trial documents
1

Trial contacts and locations

12

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Data sourced from clinicaltrials.gov

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