A Pilot, Multi-Center, Patient Preference Study Comparing Two Clindamycin/Benzoyl Peroxide Gels.

• ClinicalTrials.gov Identifier: NCT00377000
• Recruitment Status: Completed
• First Posted: September 15, 2006
• Last Update Posted: October 10, 2007
• Sponsor: Sanofi
• Information provided by: Sanofi

Study Description

Brief Summary:

Evaluate patient preference factors comparing two clindamycin/benzoyl peroxide gels. One dispensed in a pump presentation, the other in a tube presentation.

Condition or disease	Intervention/treatment	Phase
Acne Vulgaris	Drug: clindamycin 1% / benzoyl peroxide 5% gel pump; Drug: clindamycin 1% / benzoyl peroxide 5% tube	Phase 4

Study Design

• Study Type: Interventional (Clinical Trial)
• Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Crossover Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Study Start Date: November 2005
• Study Completion Date: March 2006

Arms and Interventions

Outcome Measures

Primary Outcome Measures :

1. Patient Preference Questionnaire evaluation: including product use, patient knowledge and impression of acne, as well as patient treatment
2. The incidence of all adverse events reported during the study will be summarized by treatment group
3. The signs and symptoms of irritation will be summarized descriptively by treatment group at every visit
4. Investigator irritation grading - erythema, peeling, dryness and pruritus at Baseline (Week 0), Week 2, 4, and 6

Eligibility Criteria

• Ages Eligible for Study: 12 Years to 30 Years (Child, Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

The following information on clinical trials is provided for information purposes only to allow patients and physicians to have an initial discussion about the trial. This information is not intended to be complete information about the trial, to contain all considerations that may be relevant to potential participation in the trial, or to replace the advice of a personal physician or health professional.

INCLUSION CRITERIA:

1. Patients with a clinical diagnosis of acne vulgaris of mild to moderate severity
2. Females of childbearing potential, in addition to having a negative urine pregnancy test at Visit 1, must be willing to use an acceptable form of birth control during the study.
3. Patients 18 years of age or older must provide Institutional Review Board (IRB) approved written informed consent. Patients under 18 years of age must have IRB approved written informed consent from a parent or legal guardian. Patients 12 - 17 years of age must complete an IRB approved assent form for minors.
4. Patients must be willing and able to understand the requirements of the study, abide by the restrictions, apply the medication as instructed, and return for the required study visits.
5. Patients must be in good health and free from any clinically significant disease, other than acne vulgaris, that might interfere with the study evaluations.
6. Patients who use make-up must have used the same brand of make-up for a minimum period of 2 weeks prior to Baseline and agree to not change make-up brands or types during the study.

EXCLUSION CRITERIA:

1. Patients who are pregnant, nursing, or planning a pregnancy within the study period.
2. Patients who have more than 2 nodulo-cystic lesions on the face, excluding the nose.
3. Patients who have a known hypersensitivity to any ingredients in the test products including clindamycin and benzoyl peroxide.
4. Patients who have been treated with prescription and/or over-the-counter topical products, or had a procedure performed that may impact study assessments.
5. Patients who have any systemic or dermatological disorder that has the potential to interfere with the evaluations (e.g., rosacea, seborrheic dermatitis, perioral dermatitis, corticosteroid-induced acne vulgaris, carcinoid syndrome, mastocytosis, acneform eruptions caused by medication, facial psoriasis, facial eczema, etc.).
6. Patients with clinically significant unstable medical disorders, life-threatening disease, or current malignancies.
7. Patients who engage in activities that involve excessive or prolonged exposure to sunlight.
8. Patients who consume excessive amounts of alcohol, abuse drugs, or have any condition that would compromise compliance with this protocol.
9. Patients who have been treated with an investigational drug or investigational device within a period of 30 days prior to study entry.
10. Alcoholic toners, astringents, medicated topical preparations (prescriptions and over-the-counter), or medicated make-up on the facial treatment area.
11. Abrasive cleansers or washes to the facial area.
12. New cosmetics, or new cleansers applied to the face.
13. Patients must not wear make-up at the visits, so as not to interfere with the evaluations.
14. Patients should not use a sauna within 48 hours prior to each visit.

Contacts and Locations

Sponsors and Collaborators

Sanofi

Investigators

• Study Director: Phyllis Diener, MT, ASCP; Sanofi

More Information

• ClinicalTrials.gov Identifier: NCT00377000
• Other Study ID Numbers: DL6021-0505
• First Posted: September 15, 2006
• Last Update Posted: October 10, 2007
• Last Verified: October 2007

Additional relevant MeSH terms:

Acne Vulgaris; Acneiform Eruptions; Skin Diseases; Sebaceous Gland Diseases; Clindamycin; Clindamycin palmitate; Clindamycin phosphate; Benzoyl Peroxide; Anti-Bacterial Agents; Anti-Infective Agents; Protein Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Dermatologic Agents