Back to resultsA Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Primary Purpose
Acne Vulgaris
Status
Unknown status
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
Sponsored by
About this trial
This is an interventional treatment trial for Acne Vulgaris focused on measuring Acne Vulgaris
Eligibility Criteria
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.
Sites / Locations
- Mt Sinai Hospital - Dept of DermatologyRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Active Comparator
Arm Label
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
clindamycin / tretinoin gel plus benzoyl peroxide
Arm Description
Outcomes
Primary Outcome Measures
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
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.
Secondary Outcome Measures
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Change in PIH score from baseline will be assessed. (based on a 6 point scale)
Total number of adverse events.
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
Change in Subject Self Assessment Scoring Scale
Patient rates current severity of their acne.
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Acne-QoL as completed by patient.
Full Information
NCT ID
NCT01422785
First Posted
August 12, 2011
Last Updated
August 22, 2011
Sponsor
Zeichner, Joshua, M.D.
1. Study Identification
Unique Protocol Identification Number
NCT01422785
Brief Title
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
August 2011
Overall Recruitment Status
Unknown status
Study Start Date
July 2011 (undefined)
Primary Completion Date
December 2011 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Zeichner, Joshua, M.D.
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Vulgaris
Keywords
Acne Vulgaris
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Randomized
Enrollment
40 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
Arm Type
Active Comparator
Arm Title
clindamycin / tretinoin gel plus benzoyl peroxide
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate 1.2%/tretinoin 0.025% gel alone
Intervention Description
Once daily application of the clindamycin phosphate 1.2%/tretinoin 0.025% gel in the evening
Intervention Type
Drug
Intervention Name(s)
clindamycin phosphate 1.2%/tretinoin 0.025% gel plus benzoyl peroxide 6% foaming cloths
Intervention Description
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.
Primary Outcome Measure Information:
Title
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
Description
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.
Time Frame
Weeks 2, 4, 8, 12
Secondary Outcome Measure Information:
Title
Change in Postinflammatory hyperpigmentation score at each study visit and from baseline to final visit.
Description
Change in PIH score from baseline will be assessed. (based on a 6 point scale)
Time Frame
Weeks 2, 4, 8, 12
Title
Total number of adverse events.
Description
Safety/drug-tolerance evaluated at each visit (total number of adverse events)
Time Frame
Weeks 2, 4, 8, 12
Title
Change in Subject Self Assessment Scoring Scale
Description
Patient rates current severity of their acne.
Time Frame
Weeks 2, 4, 8, 12
Title
Change in Acne-Specific Quality of Life Questionnaire (Acne-QoL)
Description
Acne-QoL as completed by patient.
Time Frame
Weeks 2, 4, 8, 12
10. Eligibility
Sex
All
Minimum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Vicky Wong
Phone
212-241-3288
Facility Information:
Facility Name
Mt Sinai Hospital - Dept of Dermatology
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Vicky Wong
Phone
212-241-3288
First Name & Middle Initial & Last Name & Degree
Joshua Zeichner, MD
12. IPD Sharing Statement
Learn more about this trial
A Study Comparing Combination Clindamycin Phosphate/Tretinoin Gel Alone Versus With Benzoyl Peroxide Foaming Cloths for Facial Acne
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