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CompletedNCT03717506Updated May 4, 2021Results posted

Bioequivalence Study of Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris

A Phase 3 interventional study of GDC 268 Lotion and Clindamycin Phosphate Lotion 1% in Acne Vulgaris, sponsored by Balmoral Medical company. Completed at 34 sites in United States. Open to participants aged 12 Years to 40 Years. Per ClinicalTrials.gov, last updated 2021-05-04.

Sponsored by Balmoral Medical company · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,236
Allocation
Randomized
Ages
12 Years to 40 Years
Sex
All
01

Study summary

The objective of the study is to evaluate the safety, tolerability, and therapeutic equivalence of GDC 268 to Clindamycin Phosphate Topical Lotion, 1% and to compare the efficacy of these two products to the GDC vehicle lotion (i.e., placebo) in the treatment of acne vulgaris.

02

Conditions studied

  • Acne Vulgaris

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Keywords

  • zits
  • pimples
  • blackheads
03

In context

Acne Vulgaris

730 studies on the registry are indexed under Acne Vulgaris; 86 are open to participants now.

This study's enrollment of 1,236 is above the median of 69 across 628 interventional studies indexed under Acne Vulgaris.

Browse Acne Vulgaris studies →

Lead sponsor

Balmoral Medical company is the lead sponsor of 4 studies on the registry; 1 is open to participants now.

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

04

Who can participate

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

Inclusion criteria

  • Male or non-pregnant, non-lactating female, ≥12 and ≤40 years of age with a clinical diagnosis of acne vulgaris.
  • Must have ≥ 25 but ≤ 100 non-inflammatory lesions (open and closed comedones) AND ≥ 20 but ≤ 70 inflammatory lesions (papules and pustules) AND ≤ 2 nodulocystic lesions (nodules and cysts) on the face (e.g., forehead, nose, cheeks, chin, upper lip) at Baseline.
  • Must be willing and able to refrain from use of all other topical products in the treatment area, all acne medications other than test article, and all antibiotics (other than test article) during the 12-week treatment period.
  • Women must be surgically sterile, or use an effective method of birth control with a negative urine pregnancy test (UPT) at the Baseline Visit (Day 1).
  • In good general health and free of any other clinically significant disease state or physical condition.
  • Subject has provided written informed consent / assent.

Exclusion criteria

Exclusion Criteria:

  • Subject is pregnant, breastfeeding, or is planning to become pregnant or breastfeed during the study.
  • 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 excessive facial hair (e.g., beards, sideburns, moustaches), facial tattoos, or other facial attributes that would interfere with diagnosis or assessment of acne vulgaris in the opinion of the investigator.
  • Subject is planning surgery during the study.
  • Subject has a history of hypersensitivity or allergy to clindamycin or lincomycin and/or any of the ingredients in the test articles.

Other Eligibility Criteria not listed above will be reviewed for each prospective subject by the study staff.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Investigator, Outcomes assessor)
Enrollment
1,236 participants (actual)

Study arms

  • Experimental
    Test product

    GDC 268 Lotion applied topically as directed.

    Drug: GDC 268 Lotion

  • Active comparator
    Reference Product

    Clindamycin Phosphate Lotion, 1% applied topically as directed.

    Drug: Clindamycin Phosphate Lotion 1%

  • Placebo comparator
    Placebo

    GDC Vehicle lotion applied topically as directed.

    Drug: GDC Vehicle Lotion

Interventions

  • DrugGDC 268 Lotion

    GDC 268 is a topical lotion

  • DrugClindamycin Phosphate Lotion 1%

    Clindamycin Phosphate Lotion is an FDA-approved drug product

  • DrugGDC Vehicle Lotion

    GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs

06

What researchers measure

Primary outcomes

  1. Mean Percent Change in the Number of Inflamed Lesions

    Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).

    Time frame: 12 weeks

  2. Mean Percent Change in the Non-inflammatory Lesion Counts

    Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.

    Time frame: 12 weeks

Secondary outcomes

  1. The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12

    Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment.

    Time frame: 12 weeks

Other outcomes

  1. Incidence of Adverse Events

    Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage.

    Time frame: Day 1 through Day 85

07

Results

Posted May 4, 2021

Participant flow

Participant flow — Overall Study
MilestoneTest ProductReference ProductPlacebo
Started496491249
Completed447441222
Not completed495027

Outcome measures

PrimaryMean Percent Change in the Number of Inflamed Lesions

Percent Change from Baseline to Week 12 in inflammatory lesion counts (Papules/Pustules).

Time frame:
12 weeks
Reported as:
Mean · percent change
Mean Percent Change in the Number of Inflamed Lesions
percent changeTest ProductReference ProductPlacebo
Mean Percent Change in the Number of Inflamed Lesions-39.4 ± 36.10-40.0 ± 36.83-35.1 ± 35.54
PrimaryMean Percent Change in the Non-inflammatory Lesion Counts

Percent Change (i.e., reduction) from Baseline to Week 12 in non-inflammatory (open and closed comedones) lesion counts.

Time frame:
12 weeks
Reported as:
Mean · percent change
Mean Percent Change in the Non-inflammatory Lesion Counts
percent changeTest ProductReference ProductPlacebo
Mean Percent Change in the Non-inflammatory Lesion Counts-52.7 ± 33.98-54.3 ± 34.44-43.0 ± 39.13
SecondaryThe Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12

Investigator's Global Assessment, IGA. Overall severity of acne was assessed using a five-point scale from 0=Clear to 4=Severe. Subjects must have had an IGA score of 2 (mild), 3 (moderate), or 4 (severe) at Baseline. Success is defined as an IGA score at week 12 that is at least 2 grades less than the baseline assessment.

Time frame:
12 weeks
Reported as:
Count of participants · Participants
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12
ParticipantsTest ProductReference ProductPlacebo
The Percentage of Subjects With a Clinical Response (IGA) of "Success" at Week 12786418
Other pre-specifiedIncidence of Adverse Events

Adverse Events (AEs) will be assessed by the investigator and the incidence (severity and causality) of any local and systemic AEs will be reported by number and percentage.

Time frame:
Day 1 through Day 85
Reported as:
Count of participants · Participants
Incidence of Adverse Events
ParticipantsTest ProductReference ProductPlacebo
Incidence of Adverse Events534129

Adverse events

Collected over 12 Weeks. Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
GroupDeathsSeriousOther
Test Product0/496 (0%)0/496 (0%)0/496 (0%)
Reference Product0/491 (0%)0/491 (0%)0/491 (0%)
Placebo0/249 (0%)0/249 (0%)0/249 (0%)

Baseline characteristics

The baseline population includes the Safety and mITT populations, defined as all randomized subjects who applied at least one dose of the test article.

Age, Customized
Age, Customized(years)Test ProductReference ProductPlaceboTotal
Mean19.5 ± 6.419.3 ± 6.019.0 ± 5.119.3 ± 6.0
Sex: Female, Male
Sex: Female, Male(Participants)Test ProductReference ProductPlaceboTotal
Female287287151725
Male20920498511
Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)Test ProductReference ProductPlaceboTotal
Hispanic or Latino216204108528
Not Hispanic or Latino280287141708
Unknown or Not Reported0000
Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)Test ProductReference ProductPlaceboTotal
Race — American Indian or Alaska Native2204
Race — Asian2017946
Race — Black or African American11911454287
Race — Native Hawaiian or Other Pacific Islander1012
Race — White346350181877
Race — Other (multiple)88420
Investigator's Global Assessment
Investigator's Global Assessment(Participants)Test ProductReference ProductPlaceboTotal
2-Mild12612966321
3-Moderate332319172823
4-Severe38431192
Non-Inflammatory Lesions
Non-Inflammatory Lesions(Lesions)Test ProductReference ProductPlaceboTotal
Mean44.9 ± 20.4144.9 ± 19.3145.5 ± 19.4245.0 ± 19.77
Inflammatory Lesions
Inflammatory Lesions(Lesions)Test ProductReference ProductPlaceboTotal
Mean28.3 ± 8.7428.4 ± 9.5527.7 ± 8.6428.2 ± 9.05
08

Study locations

34 sites
  • Site 07
    Fort Smith, Arkansas 72916, United States
  • Site 22
    Rogers, Arkansas 72758, United States
  • Site 25
    Fountain Valley, California 92708, United States
  • Site 33
    Northridge, California 91324, United States
  • Site 30
    San Diego, California 92103, United States
  • Site 44
    Aventura, Florida 33180, United States
  • Site 36
    Brandon, Florida 33511, United States
  • Site 45
    DeLand, Florida 32720, United States
  • Site 41
    Largo, Florida 33770, United States
  • Site 35
    Miami Lakes, Florida 33014, United States
  • Site 38
    Miami, Florida 33145, United States
  • Site 37
    North Miami Beach, Florida 33162, United States
  • Site 26
    Saint Petersburg, Florida 33709, United States
  • Site 42
    Tampa, Florida 33609, United States
  • Site 01
    West Palm Beach, Florida 33406, United States
  • Site 10
    Newnan, Georgia 30263, United States
  • Site 09
    Boise, Idaho 83704, United States
  • Site 05
    Rolling Meadows, Illinois 60008, United States
  • Site 02
    Plainfield, Indiana 46168, United States
  • Site 27
    Overland Park, Kansas 66215, United States
  • Site 28
    Clarkston, Michigan 48346, United States
  • Site 24
    Fridley, Minnesota 55432, United States
  • Site 49
    Omaha, Nebraska 68134, United States
  • Site 06
    High Point, North Carolina 27262, United States
  • Site 32
    Raleigh, North Carolina 27612, United States
  • Site 19
    Dublin, Ohio 43016, United States
  • Site 17
    Gresham, Oregon 97030, United States
  • Site 34
    Philadelphia, Pennsylvania 19103, United States
  • Site 20
    Warwick, Rhode Island 02886, United States
  • Site 08
    Anderson, South Carolina 29621, United States
  • Site 29
    Chattanooga, Tennessee 37421, United States
  • Site 03
    Murfreesboro, Tennessee 37130, United States
  • Site 04
    Nashville, Tennessee 37215, United States
  • Site 43
    Sugar Land, Texas 77479, United States
09

References and documents

Study documents

  • Protocol and statistical analysis plan · Sep 6, 2019

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

Individual participant data

Plan to share: No

10

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 4, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
11

Registry details

Key details

Study ID
NCT03717506
Lead sponsor
Balmoral Medical company
Responsible party
Sponsor
First posted
Oct 24, 2018
Start date
Oct 10, 2018
Primary completion
Feb 17, 2020
Completion
Apr 16, 2020
Results posted
May 4, 2021
Last update
May 4, 2021

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 Apr 2021. You cannot join it, but the record below documents what was studied.

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