- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01422785
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
August 22, 2011 updated by: Joshua Zeichner, Zeichner, Joshua, M.D.
A Pilot Study to Evaluate the Efficacy of Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Alone Versus Fixed Dose Combination Clindamycin Phosphate 1.2%/Tretinoin 0.025% Gel Plus Benzoyl Peroxide 6% Foaming Cloths in the Treatment of Facial Acne Vulgaris
There are many different factors that cause acne.
So combination treatment using different medications that can address these different factors is commonly used to treat acne.
Fixed-dose combination clindamycin phosphate 1.2% and tretinoin 0.025% gel and benzoyl peroxide 6% foaming cloths are both used to treat acne.
This study will evaluate the use of the medications when used together.
Study Overview
Status
Unknown
Conditions
Study Type
Interventional
Enrollment (Anticipated)
40
Phase
- Phase 4
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Vicky Wong
- Phone Number: 212-241-3288
Study Locations
-
-
New York
-
New York, New York, United States, 10029
- Recruiting
- Mt Sinai Hospital - Dept of Dermatology
-
Contact:
- Vicky Wong
- Phone Number: 212-241-3288
-
Principal Investigator:
- Joshua Zeichner, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
12 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Males and females ≥ 12 years old.
- Subjects must be in good general health as confirmed by medical history and physical examination.
- Females of child-bearing potential must have a negative urine pregnancy test at the baseline visit and agree to use adequate birth control during the study (barrier, oral, injection, intrauterine or abstinence).
- Clear diagnosis of facial acne vulgaris for at least 3 months.
- Subject must have a static Physician's Global Assessment (PGA) of at least 2 (mild severity), but no more than 4.
- Disease must be stable or slowly worsening for more than one week prior to entering the study.
- Subjects or their guardians must be able to read, sign, and date the informed consent, and abide by study restrictions for its duration.
Exclusion Criteria:
- Females who are pregnant, attempting to conceive, or breastfeeding.
- Subjects with known hypersensitivity to study drug.
- Subjects with very severe acne (PGA score of 5)
- Subjects with overt signs of skin atrophy, telangiectasias or other skin findings that would affect efficacy evaluation.
- Subjects with a current active skin malignancy or infection.
- Subjects requiring the use of medications known to alter the course of acne vulgaris during the study treatment.
- Subjects who have received systemic antibiotics within 2 weeks.
- Subjects using systemic corticosteroids or immunosuppressants within 28 days of entering the study.
- Subjects who have received any topical therapies for acne vulgaris within 2 weeks of entering the study.
- Subjects taking birth control pills for less than 3 months or solely for the prevention of acne.
- Subjects who are currently participating in or, within the previous 28 days, have participated in another study for the treatment of acne vulgaris.
- Subjects with clinical conditions that may post a health risk to the subject by being involved in the study or detrimentally affect regular follow-up of the subject.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
|
Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
|
Active Comparator: clindamycin / tretinoin gel plus benzoyl peroxide
|
wash face with the benzoyl peroxide foaming cloth then rinse.
then apply clindamycin phosphate 1.2%/tretinoin 0.025% gel.
both done in the evening.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in PGA scores of patients using combination clindamycin phosphate 1.2%/tretinoin 0.025% gel with or without benzoyl peroxide 6% foaming cloths for facial acne
Time Frame: Weeks 2, 4, 8, 12
|
The primary efficacy endpoint will be "Treatment Success", a static endpoint defined as a score of 0 (clear) to 1 (almost clear) at Week 12 (final study visit) by PGA scoring system.
|
Weeks 2, 4, 8, 12
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Time Frame: Weeks 2, 4, 8, 12
|
Change in PIH score from baseline will be assessed.
(based on a 6 point scale)
|
Weeks 2, 4, 8, 12
|
Total number of adverse events.
Time Frame: Weeks 2, 4, 8, 12
|
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
|
Weeks 2, 4, 8, 12
|
Change in Subject Self Assessment Scoring Scale
Time Frame: Weeks 2, 4, 8, 12
|
Patient rates current severity of their acne.
|
Weeks 2, 4, 8, 12
|
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Time Frame: Weeks 2, 4, 8, 12
|
Acne-QoL as completed by patient.
|
Weeks 2, 4, 8, 12
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
July 1, 2011
Primary Completion (Anticipated)
December 1, 2011
Study Registration Dates
First Submitted
August 12, 2011
First Submitted That Met QC Criteria
August 22, 2011
First Posted (Estimate)
August 24, 2011
Study Record Updates
Last Update Posted (Estimate)
August 24, 2011
Last Update Submitted That Met QC Criteria
August 22, 2011
Last Verified
August 1, 2011
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Skin Diseases
- Acneiform Eruptions
- Sebaceous Gland Diseases
- Acne Vulgaris
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Enzyme Inhibitors
- Antineoplastic Agents
- Dermatologic Agents
- Anti-Bacterial Agents
- Protein Synthesis Inhibitors
- Keratolytic Agents
- Clindamycin
- Clindamycin palmitate
- Clindamycin phosphate
- Benzoyl Peroxide
- Tretinoin
Other Study ID Numbers
- GCO 10-1602
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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