ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03717506
Recruitment Status : Recruiting
First Posted : October 24, 2018
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Gage Development Company, LLC

Brief 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.

Condition or disease Intervention/treatment Phase
Acne Vulgaris Drug: GDC 268 Lotion Drug: Clindamycin Phosphate Lotion 1% Drug: GDC Vehicle Lotion Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Group Comparison Study to Determine the Therapeutic Equivalence of GDC 268 and Clindamycin Phosphate Topical Lotion, 1% in Subjects With Acne Vulgaris
Actual Study Start Date : October 3, 2018
Estimated Primary Completion Date : October 2019
Estimated Study Completion Date : October 2019


Arm Intervention/treatment
Experimental: Test product
GDC 268 Lotion applied topically as directed.
Drug: GDC 268 Lotion
GDC 268 is a topical lotion

Active Comparator: Reference Product
Clindamycin Phosphate Lotion, 1% applied topically as directed.
Drug: Clindamycin Phosphate Lotion 1%
Clindamycin Phosphate Lotion is an FDA-approved drug

Placebo Comparator: Placebo
GDC Vehicle lotion applied topically as directed.
Drug: GDC Vehicle Lotion
GDC Vehicle Lotion contains 0.0% of active drug and is matched to the other two active test drugs




Primary Outcome Measures :
  1. Mean Percent Change in the Number of Inflamed Lesions (Papules/Pustules) [ Time Frame: 12 weeks ]
  2. Mean percent change in the non-inflammatory (open and closed comedones) lesion counts [ Time Frame: 12 weeks ]

Secondary Outcome Measures :
  1. The proportion of Subjects with a clinical response (IGA) of "success" at week 12. Success should be defined as an IGA score that is at least 2 grades less than the baseline assessment. [ Time Frame: 12 weeks ]

Other Outcome Measures:
  1. Incidence of Adverse Events [ Time Frame: Day 1 through Day 85 ]
    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.



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   12 Years to 40 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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:

  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03717506


Contacts
Contact: Oleg Khatsenko 858-571-1800 ClinicalResearch@therapeuticsinc.com

  Show 34 Study Locations
Sponsors and Collaborators
Gage Development Company, LLC

Responsible Party: Gage Development Company, LLC
ClinicalTrials.gov Identifier: NCT03717506     History of Changes
Other Study ID Numbers: GDC-268-001
First Posted: October 24, 2018    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Gage Development Company, LLC:
zits
pimples
blackheads

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Sebaceous Gland Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action