Efficacy & Safety of Clindamycin and Tretinoin in Acne

Acne Clinical Trial

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01111994
• Other study ID #: VDC2009Z
• Status: Active, not recruiting
• Phase: Phase 4
• First received: April 26, 2010
• Last updated: May 19, 2010
• Start date: November 2009
• Est. completion date: April 2010

Study information

• Verified date: May 2010
• Source: Callender Center for Clinical Research
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 30
• Est. completion date: April 2010
• Est. primary completion date: March 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years and older

Eligibility

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).

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne
• Hyperpigmentation

Intervention

Drug:
• Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months

Locations

Country	Name	City	State
United States	Callender Center for Clinical Research	Mitchellville	Maryland
United States	Society Hill Dermatology	Philadelphia	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Callender Center for Clinical Research	Society Hill Dermatology

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Improvement of acne and post inflammatory hyperpigmentation		3 months	Yes

External Links

•   Home page to the Callender Skin & Laser Center that includes "Research Studies" section