Efficacy & Safety of Clindamycin and Tretinoin in Acne
Primary Purpose
Acne
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
Sponsored by
About this trial
This is an interventional treatment trial for Acne focused on measuring hyperpigmentation
Eligibility Criteria
Inclusion Criteria:
- Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
- Photo skin types IV - VI
- Ages 12 and older
- Both sexes
- Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
- Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives
Exclusion Criteria:
- Seborrheic dermatitis
- PIH of solely dermal origin
- Acne vulfaris known to be resistant to oral antibiotics
- Use of erythromycin-containing products
- Use of neuromuscular blocking agents
- Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).
Sites / Locations
- Callender Center for Clinical Research
- Society Hill Dermatology
Outcomes
Primary Outcome Measures
Improvement of acne and post inflammatory hyperpigmentation
Secondary Outcome Measures
Full Information
NCT ID
NCT01111994
First Posted
April 26, 2010
Last Updated
May 19, 2010
Sponsor
Callender Center for Clinical Research
Collaborators
Society Hill Dermatology
1. Study Identification
Unique Protocol Identification Number
NCT01111994
Brief Title
Efficacy & Safety of Clindamycin and Tretinoin in Acne
Official Title
Efficacy & Safety of Clindamycin Phosphase 1.2% and Tretinoin 0.025% Gel vs. Vehicle for the Treatment of Acne and Acne-Induced Post Inflammatory Hyperpigmentation in Patients With Skin of Color
Study Type
Interventional
2. Study Status
Record Verification Date
May 2010
Overall Recruitment Status
Unknown status
Study Start Date
November 2009 (undefined)
Primary Completion Date
March 2010 (Anticipated)
Study Completion Date
April 2010 (Anticipated)
3. Sponsor/Collaborators
Name of the Sponsor
Callender Center for Clinical Research
Collaborators
Society Hill Dermatology
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
The purpose of this study is ascertain the efficacy and safety of Clindamycin
Phosphate 1.2% and Tretinoin 0.025% in the treatment of Acne and Post
Inflammatory Hyperpigmentation in patients with skin of color.
Detailed Description
Acne is a chronic disorder of the pilosebaceous glands characterized by
inflammatory papules, pustules, opened and closed comedones, cysts and
nodules. Post inflammatory hyperpigmentation is a condition in which an
inflammation from a disease such as acne, trauma, or abrasion results in areas
of the skin with increased melanin content compared to the surrounding skin.
There are several treatments available for acne, which include benzoyl
peroxide,antibiotics (topical or oral), and topical retinoids (tretinoin,
tazarotene, adapalene). Combination therapy, such as topical retinoid and
clindamycin, has been shown to be more effective than monotherapy in
addressing all pathogenic factors of acne.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne
Keywords
hyperpigmentation
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
Other Intervention Name(s)
Ziana Gel
Intervention Description
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months
Primary Outcome Measure Information:
Title
Improvement of acne and post inflammatory hyperpigmentation
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Mild to moderate facial acne and mild to moderate post-inflammatory hyperpigmentation
Photo skin types IV - VI
Ages 12 and older
Both sexes
Two week washout period for topical anti-acne medications, medicated cosmetics,and bleaching products
Thirty day washout period for oral corticosteroids, oral antibiotics,and oral contraceptives
Exclusion Criteria:
Seborrheic dermatitis
PIH of solely dermal origin
Acne vulfaris known to be resistant to oral antibiotics
Use of erythromycin-containing products
Use of neuromuscular blocking agents
Pregnancy, breastfeeding, a positive pregnancy test in the office, or plans to become pregnant. Women of childbearing age must use reliable forms of contraception (e.g., abstinence, oral contraceptives, or spermicide and condoms).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Valerie Callender, MD
Organizational Affiliation
Callender Center for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Callender Center for Clinical Research
City
Mitchellville
State/Province
Maryland
ZIP/Postal Code
20721
Country
United States
Facility Name
Society Hill Dermatology
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
12. IPD Sharing Statement
Links:
URL
http://www.callenderskin.com
Description
Home page to the Callender Skin & Laser Center that includes "Research Studies" section
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Efficacy & Safety of Clindamycin and Tretinoin in Acne
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