Efficacy & Safety of Clindamycin and Tretinoin in Acne

NCT ID: NCT01111994

Last Updated: 2010-05-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-11-30

Study Completion Date

2010-04-30

Brief Summary

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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

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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.

Conditions

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Acne

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel

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

Intervention Type DRUG

Other Intervention Names

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Ziana Gel

Eligibility Criteria

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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).
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Society Hill Dermatology

OTHER

Sponsor Role collaborator

Callender Center for Clinical Research

OTHER

Sponsor Role lead

Responsible Party

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Callender Center for Clinical Research

Principal Investigators

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Valerie Callender, MD

Role: PRINCIPAL_INVESTIGATOR

Callender Center for Clinical Research

Locations

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Callender Center for Clinical Research

Mitchellville, Maryland, United States

Site Status

Society Hill Dermatology

Philadelphia, Pennsylvania, United States

Site Status

Countries

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United States

Other Identifiers

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VDC2009Z

Identifier Type: -

Identifier Source: org_study_id

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