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Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

Primary Purpose

Acne

Status
Completed
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Epiduo vehicle gel
CD07223
CD07223
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
Sponsored by
Galderma R&D
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne

Eligibility Criteria

18 Years - 35 Years (Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • subject has a clinical diagnosis of acne vulgaris with facial involvement
  • the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face

Exclusion Criteria:

  • subject has a severe acne form or secondary acne form
  • the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face
  • the subject has a known allergy or sensitivity to any of the components of the study products
  • subject is not willing to respect wash-out periods for topical and/or systemic treatments

Sites / Locations

  • Burke Pharmaceuticals
  • Dermatology Specialist PSC
  • Grekin Skin Institute
  • TKL Research
  • Piedmont Medical Research
  • Cetero
  • Derm Research, Inc
  • J & S Studies
  • Education and Research Foundation, Inc

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Active Comparator

Arm Label

CD07223 1.5% gel

CD07223 0.5% gel

Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel

Arm Description

500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face

500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces

Outcomes

Primary Outcome Measures

Total acne lesion count
change in total number of acne lesion count from baseline to end of treatment
Percent change of acne lesion count
Percent change of acne lesion count from baseline to end of treatment

Secondary Outcome Measures

Lesion counts- Inflammatory
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Lesion count- non-inflammatory
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Lesion counts- Inflammatory
Percent change of acne lesion count from baseline at each evaluation visit
Lesion count- non-inflammatory
Percent change of acne lesion count from baseline at each evaluation visit

Full Information

First Posted
April 19, 2010
Last Updated
February 16, 2021
Sponsor
Galderma R&D
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1. Study Identification

Unique Protocol Identification Number
NCT01106807
Brief Title
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne
Official Title
Exploratory Study to Evaluate the Efficacy and Safety of CD07223 1.5% Gel and 0.5% Gel in Subjects With Acne
Study Type
Interventional

2. Study Status

Record Verification Date
April 2012
Overall Recruitment Status
Completed
Study Start Date
April 2010 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
September 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Galderma R&D

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of the study is to evaluate the efficacy of CD07223 1.5% Gel and 0.5% gel in reducing inflammatory, non-inflammatory, and total acne lesion counts after 6 weeks of twice daily applications. The study will also evaluate the safety of the study products using tolerance and adverse event data.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
73 (Actual)

8. Arms, Groups, and Interventions

Arm Title
CD07223 1.5% gel
Arm Type
Experimental
Arm Description
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
Arm Title
CD07223 0.5% gel
Arm Type
Experimental
Arm Description
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks and Epiduo vehicle gel on the other half-face
Arm Title
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
Arm Type
Active Comparator
Arm Description
500 microliters of Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel on one half-face and 500 microliters of the Epiduo vehicle gel on the other half-face in the morning and in the afternoon, 500 microliters of Epiduo vehicle gel on both half-faces
Intervention Type
Drug
Intervention Name(s)
Epiduo vehicle gel
Intervention Description
500 microliters of Epiduo vehicle gel on one half-face twice daily for six weeks
Intervention Type
Drug
Intervention Name(s)
CD07223
Intervention Description
500 microliters of CD07223 1.5% gel on one half-face twice daily for six weeks
Intervention Type
Drug
Intervention Name(s)
CD07223
Intervention Description
500 microliters of CD07223 0.5% gel on one half-face twice daily for six weeks
Intervention Type
Drug
Intervention Name(s)
Epiduo (adapalene and benzoyl peroxide) 0.1%/2.5% gel
Intervention Description
500 microliters Epiduo Gel on one of the half-face for the morning dose
Primary Outcome Measure Information:
Title
Total acne lesion count
Description
change in total number of acne lesion count from baseline to end of treatment
Time Frame
6 weeks
Title
Percent change of acne lesion count
Description
Percent change of acne lesion count from baseline to end of treatment
Time Frame
6 weeks
Secondary Outcome Measure Information:
Title
Lesion counts- Inflammatory
Description
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Time Frame
6 weeks
Title
Lesion count- non-inflammatory
Description
change in lesion count from baseline at each evaluation visit; efficacy preference at the end of treatment by investigator and subject
Time Frame
6 weeks
Title
Lesion counts- Inflammatory
Description
Percent change of acne lesion count from baseline at each evaluation visit
Time Frame
6 weeks
Title
Lesion count- non-inflammatory
Description
Percent change of acne lesion count from baseline at each evaluation visit
Time Frame
6 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: subject has a clinical diagnosis of acne vulgaris with facial involvement the subject has at least 15 inflammatory lesions and 25 non-inflammatory lesions (excluding the nose) but no more than 2 nodules on the face Exclusion Criteria: subject has a severe acne form or secondary acne form the number of inflammatory or non-inflammatory lesions on one half-face is greater than twice the number on the other half-face the subject has a known allergy or sensitivity to any of the components of the study products subject is not willing to respect wash-out periods for topical and/or systemic treatments
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Michael Graeber, MD
Organizational Affiliation
Galderma R&D
Official's Role
Study Director
Facility Information:
Facility Name
Burke Pharmaceuticals
City
Hot Springs
State/Province
Arkansas
Country
United States
Facility Name
Dermatology Specialist PSC
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Grekin Skin Institute
City
Warren
State/Province
Michigan
ZIP/Postal Code
48088
Country
United States
Facility Name
TKL Research
City
Rochelle Park
State/Province
New Jersey
ZIP/Postal Code
07662
Country
United States
Facility Name
Piedmont Medical Research
City
Winston-Salem
State/Province
North Carolina
ZIP/Postal Code
27103
Country
United States
Facility Name
Cetero
City
Fargo
State/Province
North Dakota
ZIP/Postal Code
58104
Country
United States
Facility Name
Derm Research, Inc
City
Austin
State/Province
Texas
ZIP/Postal Code
78759
Country
United States
Facility Name
J & S Studies
City
Bryan
State/Province
Texas
ZIP/Postal Code
77845
Country
United States
Facility Name
Education and Research Foundation, Inc
City
Lynchburg
State/Province
Virginia
ZIP/Postal Code
24501
Country
United States

12. IPD Sharing Statement

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Exploratory Study to Evaluate the Efficacy and Safety of CD07223 Gel in Subjects With Acne

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