| City: |
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Fremont |
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State:
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CA |
| Zip Code: |
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94538 |
| Conditions: |
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Acne Vulgaris |
| Purpose: |
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This is a single-blind (investigator-blinded), randomized, parallel group, single center
study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac
Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately
40 male and female subjects will be enrolled (20 per study group).
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| Study summary: |
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This is a single-blind (investigator-blinded), randomized, parallel group, single center
study to evaluate the tolerability and efficacy of combination therapy with Duac Gel/Tazorac
Cream and Acanya Gel/Tazorac Cream for the treatment of facial acne vulgaris. Approximately
40 male and female subjects will be enrolled (20 per study group).
Subjects will participate in the study for 12 weeks; visits will be scheduled at baseline
and at weeks 1, 2, 4, 8, and 12 (total of 6 visits). Eligible subjects will be randomized
at baseline to 1 of the 2 study groups in a 1:1 ratio (Duac Gel/Tazorac Cream to Acanya
Gel/Tazorac Cream). Subjects will apply either Duac Gel or Acanya Gel to the face each
morning and apply Tazorac Cream to the face each evening.
Tolerability will be evaluated through subject assessments of burning/stinging, itching, and
oiliness and through investigator assessments of peeling, erythema, and dryness. In
addition, subjects will evaluate their overall skin comfort and record the usage of
moisturizer and sunscreen, if needed. Efficacy will be assessed through lesion counts
(total, inflammatory and noninflammatory) and ISGA. Safety will be assessed by evaluating
adverse events (AEs), concomitant medication use, and withdrawals from the study.
This is an investigator-blinded study; therefore, subjects and study-center staff will not
be blinded to study treatment allocation. Subjects (and parents or legal guardians) and
study-center staff will be instructed not to reveal study product allocation to the
investigator. |
| Criteria: |
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Inclusion Criteria:
- Male or female 12-45 years of age at time of consent.
- Capable of understanding and willing to provide signed and dated written voluntary
informed consent before any protocol-specific procedures are performed.
- Documented diagnosis of acne vulgaris.
- Lesion count: 20 to 50 inflammatory and 30 to 100 noninflammatory facial lesions
excluding nose, and ≤ 1 small nodular lesion. Cystic lesions are not allowed at
baseline.
- Investigator Static Global Assessment of 3 or 4 at Baseline.
- Female subjects of childbearing potential must have a regular menstrual cycle and a
negative urine pregnancy test within 2 weeks prior to study entry.
- 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.
- Women who are not currently sexually active must agree to use a medically-acceptable
method of contraception should they become sexually active while participating in the
study.
Exclusion Criteria:
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Clinically relevant finding at baseline or medical history of severe systemic
diseases or 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 (eg,
ulcerative colitis, pseudomembranous colitis, chronic diarrhea, celiac disease or a
history of antibiotic-associated colitis) or similar symptoms.
- Concurrent use of medications known to be photosensitizers because of the possibility
of increased phototoxicity.
- Concomitant use of neuromuscular blocking agents.
- Use of topical anti-acne medications within the past 2 weeks.
- Use of topical antibiotics on the face within the past 2 weeks or systemic
antibiotics within the past 4 weeks.
- Use of topical corticosteroids on the face or systemic corticosteroids within the
past 2 to 4 weeks, respectively. Use of inhaled, intra-articular or intra lesional
(other than for facial acne lesions) steroids is acceptable.
- Use of systemic retinoids, such as Isotretinoin, within the past 6 months.
- Concomitant use of facial products such as astringents, toners, peels, masks, washes
or soaps containing benzoyl peroxide, sulfacetamide sodium or salicylic acid,
non-mild facial cleansers, or moisturizers that contain retinol, salicylic acid, or
α- or β hydroxy acids.
- Concomitant use of medications that are reported to exacerbate acne, as these may
impact efficacy assessments. Iron supplements and folate are acceptable.
- Facial procedures (eg, chemical peel, lasers/lights, photodynamic therapy,
microdermabrasion, artificial ultraviolet therapy) within the past 4 weeks.
- Known hypersensitivity or previous allergic reaction to any component(s) or
excipient(s) of the study products.
- Use of any investigational medications or treatments within the past 4 weeks.
- Treatment with estrogens for 12 weeks or less immediately prior to starting study
product and have not been prescribed for the treatment of Acne Vulgaris. Subjects
that have been treated with estrogens, androgens, or anti androgenic agents for more
than 12 weeks prior to start of study treatment are allowed to enroll as long as they
do not expect to change dose, medication, or discontinue use during the study.
- Evidence of recent alcohol or drug abuse.
- Live in the same household as currently enrolled subjects.
- Employee of the investigator, a clinical research organization, or Stiefel, who is
involved in the study or an immediate family member of an employee involved in the
study. |
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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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April 13, 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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