CompletedNCT03522441Updated Oct 5, 2020Results posted

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

A Phase 3 interventional study of Clindamycin 1% Gel and Placebo in Acne Vulgaris, sponsored by Akorn, Inc.. Completed at 12 sites in 2 countries. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2020-10-05.

Sponsored by Akorn, Inc. · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 1,125
Allocation: Randomized
Ages: 12 Years to 40 Years
Sex: All

Study summary

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.

Conditions studied

Acne Vulgaris

Browse trials for

Acne Vulgaris 727

Who can participate

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

Eligibility 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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 1,125 participants (actual)

Study arms

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

Interventions

DrugClindamycin 1% Gel
Topical gel
DrugPlacebo
Topical Placebo gel

What researchers measure

Primary outcomes

Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
Time frame: Percent change from baseline to 12 weeks
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
Time frame: Percent change in baseline to 12 weeks

Results

Posted Oct 5, 2020

Participant flow

Participant flow — Overall Study
Milestone	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Started	450	450	225
Completed	424	431	214
Not completed	26	19	11

Outcome measures

PrimaryPercent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks

Time frame:: Percent change from baseline to 12 weeks
Reported as:: Mean · % mean change from baseline

Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks
% mean change from baseline	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Percent Change in the Number of Inflamed Lesions (Papules/Pustules)- Time Frame: Baseline to 12 Weeks	-66.22 ± 28.002	-72 ± 27.19	-16.02 ± 34.238

PrimaryPercent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week

Time frame:: Percent change in baseline to 12 weeks
Reported as:: Mean · percent change from baseline

Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week
percent change from baseline	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo
Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts - Change in Baseline to 12 Week	-50.45 ± 29.934	-57.42 ± 25.709	-46.07 ± 29.922

Adverse events

Collected over 6 months. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Clindamycin 1% Gel (Akorn Pharmaceuticals)	0/450 (0%)	0/450 (0%)	0/450 (0%)
Clindamycin 1% Gel (Greenstone LLC)	0/450 (0%)	0/450 (0%)	0/450 (0%)
Placebo	0/225 (0%)	0/225 (0%)	0/225 (0%)

Baseline characteristics

Age, Continuous
Age, Continuous(year)	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo	Total
Mean	21.3 ± 7.38	20.6 ± 6.79	21.3 ± 7.01	21.0 ± 7.08

Sex: Female, Male
Sex: Female, Male(Participants)	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo	Total
Female	163	177	88	428
Male	287	273	137	697

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Clindamycin 1% Gel (Akorn Pharmaceuticals)	Clindamycin 1% Gel (Greenstone LLC)	Placebo	Total
American Indian or Alaska Native	0	0	0	0
Asian	7	1	1	9
Native Hawaiian or Other Pacific Islander	1	0	0	1
Black or African American	173	170	73	416
White	264	274	148	686
More than one race	5	5	3	13
Unknown or Not Reported	0	0	0	0

Study locations

12 sites

Site 11
Encino, California 91436, United States
Site 10
Sherman Oaks, California 91403, United States
Site 1
Brandon, Florida 33511, United States
Site 4
Miramar, Florida 33027, United States
Site 5
Miramar, Florida 33027, United States
Site 2
Tampa, Florida 33069, United States
Site 3
Tampa, Florida 33618, United States
Site 12
High Point, North Carolina 27262, United States
Site 8
El Paso, Texas 79902, United States
Site 9
El Paso, Texas 79925, United States
Site 6
Belize City, Belize
Site 7
Belize City, Belize

References and documents

Study documents

Protocol and statistical analysis plan · Dec 23, 2018

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Registry details

Key details

Study ID: NCT03522441
Lead sponsor: Akorn, Inc.
Responsible party: Sponsor
First posted: May 11, 2018
Start date: Apr 27, 2018
Primary completion: Apr 22, 2019
Completion: Apr 22, 2019
Results posted: Oct 5, 2020
Last update: Oct 5, 2020

Oversight

Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2018. You cannot join it, but the record below documents what was studied.

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