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View Clinical Trial (Medical Research Study)
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A Study to Evaluate Tolerability of Two Topical Drug Products in the Treatment of Facial Acne - NCT00964223-48088 (Clinical Trial 306736)
Permalink: http://www.ClinicalConnection.com/exp/ExpandedPatientViewStudy306736.aspx
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| City: |
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Warren |
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State:
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MI |
| Zip Code: |
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48088 |
| Conditions: |
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Acne Vulgaris |
| Purpose: |
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Multi-center, single-blind, randomized, comparative, split-face study. The duration of the
study is 8 weeks. Commencing at baseline, subjects will apply once daily both clindamycin
and benzoyl peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face
fashion (allocation to left and right side randomly assigned) for an initial 2 weeks. After
visit 3, subjects will commence application of clindamycin and benzoyl peroxide gel to the
entire face for an additional 6 weeks.
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| Study summary: |
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Multi-center, single-blind, randomized, comparative, split-face study. The duration of the
study is 8 weeks and consists of a baseline visit and visits at weeks 1, 2, 5 and 8.
Commencing at baseline, subjects will apply once daily both clindamycin and benzoyl
peroxide gel and benzoyl peroxide/adapalene gel in a bilateral split-face fashion
(allocation to left and right side randomly assigned) for an initial 2 weeks. After visit 3
subjects will commence application of clindamycin and benzoyl peroxide gel to the entire
face for an additional 6 weeks.
Blinding This is an investigator-blinded study; therefore, subjects and study-center staff
will not be blinded to study treatment allocation (ie, left vs. right side application).
During the first 2 weeks, the investigator will be unaware of which study product is being
used on either side of the face. Subjects and study-center staff will be instructed not to
reveal study treatment allocation to the investigator. Subjects will be instructed not to
use study product in the presence of the investigator. |
| Criteria: |
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Inclusion Criteria:
- Male or female subjects at least 18 years of age, in good general health with
documented diagnosis of facial acne vulgaris.
- Sexually active females of childbearing potential participating in the study must
agree to use a medically acceptable method of contraception while receiving
protocol-assigned product.
- Subjects willing to follow therapeutic instructions including avoidance of any other
topical facial or systemic acne therapy during the conduct of the study.
- Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol specific procedures are performed.
Exclusion Criteria:
- Female subjects who are pregnant, trying to become pregnant or breastfeeding.
- Subjects who have any clinically relevant finding at their baseline physical
examination or medical history such as severe systemic diseases, diseases of the
facial skin, other than acne vulgaris.
- Facial hair that may obscure the accurate assessment of acne grade.
- History or presence of regional enteritis or inflammatory bowel disease (e.g.,
ulcerative colitis, pseudomembranous colitis, chronic diarrhea, or a history of
antibiotic-associated colitis) or similar symptoms.
- Use of topical antibiotics on the face and systemic antibiotics within the past 2 and
4 weeks, respectively.
- Use of topical corticosteroids on the face or systemic corticosteroids within the
past 4 weeks. Use of inhaled, intra-articular or intra-lesional (other than for
facial acne lesions) steroids is acceptable.
- Use of systemic retinoids within the past 6 months.
- Concurrent use of drugs known to be photosensitizers (e.g., thiazides, tetracyclines,
fluoroquinolones, phenothiazines, sulfonamides) because of the possibility of
increased phototoxicity.
- Concomitant use of neuromuscular blocking agents. Clindamycin has neuromuscular
blocking activities, which may enhance the action of other neuromuscular blocking
agents.
- Use of topical anti-acne medications within the past 2 weeks.
- Use of any investigational drugs or treatments during the study or within 4 weeks of
the baseline visit. |
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| Study is available at: |
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Grekin Skin Institute
Warren, MI 48088
United States
Primary Contact:
Jennifer A Meitzner, MD
Phone: 586-759-5525 |
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If you are interested in this clinical trial please use the contact information above. If you would like to get additional information about this clinical trial please visit ClinicalTrials.gov.
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| Data Source: |
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ClinicalTrials.gov |
| Date Processed: |
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February 17, 2010 |
Modifications to
this listing: |
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Only selected fields are shown, please use the link
above to view all information about this clinical trial. |
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Clinical trials are medical research studies designed to test the safety and/or
effectiveness of new drugs, devices, or treatments in humans. These studies are
conducted worldwide for a range of conditions and illnesses. Learn more about
clinical research and participating in a study at
About Clinical Trials.
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