Efficacy & Safety of Clindamycin and Tretinoin in Acne

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2010 by Callender Center for Clinical Research.
Recruitment status was  Active, not recruiting
Sponsor:
Collaborator:
Society Hill Dermatology
Information provided by:
Callender Center for Clinical Research
ClinicalTrials.gov Identifier:
NCT01111994
First received: April 26, 2010
Last updated: May 19, 2010
Last verified: May 2010
  Purpose

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 Intervention Phase
Acne
Drug: Clindamycin Phosphate 1.2% and Tretinoin 0.025% Gel
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, 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

Resource links provided by NLM:


Further study details as provided by Callender Center for Clinical Research:

Primary Outcome Measures:
  • Improvement of acne and post inflammatory hyperpigmentation [ Time Frame: 3 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: November 2009
Estimated Study Completion Date: April 2010
Estimated Primary Completion Date: March 2010 (Final data collection date for primary outcome measure)
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
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.

  Eligibility

Ages Eligible for Study:   12 Years and older
Genders Eligible for Study:   Both
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Additional Information:
No publications provided

Responsible Party: Valerie D. Callender, M.D., Callender Center for Clinical Research
ClinicalTrials.gov Identifier: NCT01111994     History of Changes
Other Study ID Numbers: VDC2009Z
Study First Received: April 26, 2010
Last Updated: May 19, 2010
Health Authority: United States: Institutional Review Board

Keywords provided by Callender Center for Clinical Research:
hyperpigmentation

Additional relevant MeSH terms:
Acne Vulgaris
Hyperpigmentation
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Pigmentation Disorders
Clindamycin
Clindamycin-2-phosphate
Tretinoin
Protein Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Anti-Bacterial Agents
Anti-Infective Agents
Therapeutic Uses
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on July 29, 2014