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Efficacy & Safety of Clindamycin and Tretinoin in Acne

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ClinicalTrials.gov Identifier: NCT01111994
Recruitment Status : Unknown
Verified May 2010 by Callender Center for Clinical Research.
Recruitment status was:  Active, not recruiting
First Posted : April 28, 2010
Last Update Posted : May 20, 2010
Sponsor:
Collaborator:
Society Hill Dermatology
Information provided by:
Callender Center for Clinical Research

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.


Condition or disease Intervention/treatment Phase
Acne Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel Phase 4

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
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 Start Date : November 2009
Estimated Primary Completion Date : March 2010
Estimated Study Completion Date : April 2010



Intervention Details:
  • Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
    Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel QD for 3 months
    Other Name: Ziana Gel


Primary Outcome Measures :
  1. Improvement of acne and post inflammatory hyperpigmentation [ Time Frame: 3 months ]


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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).

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): NCT01111994


Locations
United States, Maryland
Callender Center for Clinical Research
Mitchellville, Maryland, United States, 20721
United States, Pennsylvania
Society Hill Dermatology
Philadelphia, Pennsylvania, United States, 19107
Sponsors and Collaborators
Callender Center for Clinical Research
Society Hill Dermatology
Investigators
Principal Investigator: Valerie Callender, MD Callender Center for Clinical Research

Additional Information:
Responsible Party: Valerie D. Callender, M.D., Callender Center for Clinical Research
ClinicalTrials.gov Identifier: NCT01111994     History of Changes
Other Study ID Numbers: VDC2009Z
First Posted: April 28, 2010    Key Record Dates
Last Update Posted: May 20, 2010
Last Verified: May 2010

Keywords provided by Callender Center for Clinical Research:
hyperpigmentation

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases
Clindamycin
Clindamycin palmitate
Clindamycin phosphate
Tretinoin
Anti-Bacterial Agents
Anti-Infective Agents
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents