Last updated: 11/07/2018 07:56:31
A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects with Common Facial Acne
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A Multicenter, Randomized, Double-Blind, Vehicle-Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects with Acne Vulgaris
Trial description: The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Absolute change in lesion counts (LCs) from Baseline to Week 12
Timeframe: Baseline (Week 0/Day 1) and Week 12
Number of participants with a minimum 2-grade (G) improvement in the Investigator Static Global Assessment (ISGA) score from Baseline at Week 12
Timeframe: Baseline (Week 0/Day 1) and Week 12
Number of participants with an ISGA score of 0 or 1 at Week 12
Timeframe: Week 12
Secondary outcomes:
Percent change in LC from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change from Baseline in LC at Weeks 2, 4, and 8
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Time to a 50 percent reduction in Total Lesion Counts (TLC)
Timeframe: Baseline (Week 0/Day 1) to Week 12
Number of participants with a minimum 2 G improvement in ISGA score at Weeks 2, 4, and 8
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, and 8
Number of participants with an ISGA score of 0 or 1 at Weeks 2, 4, and 8
Timeframe: Weeks 2, 4, and 8
Number of participants with a Subject’s Global Assessment (SGA) score of 0 or 1 at Weeks 2, 4, 8, and 12
Timeframe: Weeks 2, 4, 8, and 12
Number of participants with a 2-G improvement in ISGA score and an ISGA score of 0 or 1 at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change in papule count from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change in pustule count from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change in nodule count from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change in open comedone count from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Absolute change in closed comedone count from Baseline at Weeks 2, 4, 8, and 12
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Change in Dermatology Life Quality Index (DLQI) score from Baseline at Weeks 2, 4, 8, and 12 in participants 17 years of age or older
Timeframe: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12
Change in Children’s Dermatology Life Quality Index (CDLQI) from Baseline at Week 2, 4, 8 and 12 in participant's with 16 years old or younger
Timeframe: Baseline (Week 0/Day 1); Week 2, 4, 8, and 12
Number of participants with the indicated local tolerability assessment for erythema as evaluated by the Investigator
Timeframe: Baseline (Week 0/Day 1) to Week 12
Number of participants with the indicated local tolerability assessment for drying as evaluated by the Investigator
Timeframe: Baseline (Week 0/Day 1) to Week 12
Number of participants with the indicated local tolerability assessment for peeling as evaluated by the Investigator
Timeframe: Baseline (Week 0/Day 1) to Week 12
Number of participants with the indicated local tolerability assessment for itching as evaluated by the participants
Timeframe: Baseline (Week 0/Day 1) to Week 12
Number of participants with the indicated local tolerability assessment for burning/stinging as evaluated by the participants
Timeframe: Baseline (Week 0/Day 1) to Week 12
Interventions:
Drug: Tazarotene Foam
Drug: Vehicle Foam
Enrollment:
742
Observational study model:
Not applicable
Primary completion date:
2010-09-11
Time perspective:
Not applicable
Clinical publications:
Steve Feldman, Cary Werner, Alessandra Alio. The efficacy and tolerability of tazarotene foam, 0.1% in the treatment of acne vulgaris in 2 multicenter, randomized, vehicle-controlled, double-blind studies. J Drugs Dermatol. 2013;12(4):438-446.
Medical condition
Acne Vulgaris
Product
tazarotene
Collaborators
GSK
Study date(s)
October 2009 to November 2010
Type
Interventional
Phase
3
Participation criteria
Sex
Female & Male
Age
12 - 45 years
Accepts healthy volunteers
No
- Male or female age 12 through 45 years, inclusive, who is in good general health.
- An ISGA score of 3 or greater at baseline.
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Use of topical antibiotics on the face within the past 2 weeks.
Inclusion and exclusion criteria
Inclusion criteria:
- Male or female age 12 through 45 years, inclusive, who is in good general health.
- An ISGA score of 3 or greater at baseline.
- Lesion counts meeting both of the following criteria: a. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (<5mm), with NO cystic lesions. b. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions.
- Regular menstrual cycle prior to study entry for females of childbearing potential.
- 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. A woman of childbearing potential is defined as one who is biologically capable of becoming pregnant; including perimenopausal women who are less than 2 years from their last menses. Women who are not currently sexually active must agree to use medically accepted method of contraception should they become sexually active while participating in the study. Male subjects and/or their partners must use a medically acceptable form of contraception.
- Capable of understanding and willing to provide signed and dated written voluntary informed consent before any protocol specific procedures are performed.
- Ability and willingness to follow all study procedures, attend all scheduled visits, and successfully complete the study.
Negative urine pregnancy test for females of childbearing potential.
Exclusion criteria:
- Female who is pregnant, trying to become pregnant, or breast feeding.
- Use of topical antibiotics on the face within the past 2 weeks.
- Use of systemic antibiotics for acne treatment within the past 4 weeks.
- Concurrent use of medications known to be photosensitizers (eg, thiazides, tetracyclines) because of the possibility of augmented photosensitivity.
- Use of topical corticosteroids on the face within the past 2 weeks or systemic corticosteroids within the past 4 weeks.
- Use of systemic retinoids (eg, isotretinoin) within the past 6 months.
- Treatment with estrogens, androgens, or anti-androgenic agents for 12 weeks or less immediately prior to study enrollment. Subjects that have been treated with these medications for more than 12 consecutive weeks prior to study enrollment are allowed to enroll as long as they do not expect to change the dose or drug, or to discontinue use during the study and it has not been indicated for the treatment of acne vulgaris.
- Use of topical anti-acne medications (eg, benzoyl peroxide, retinoids, or salicylates) within the past 2 weeks.
- Concomitant use of facial products such as: abradants, facials, peels containing glycolic or other acids, masks, washes or soaps.
- Concomitant use of medications that are reported to exacerbate acne (eg, mega-doses of certain vitamins, haloperidol, and immunosuppressants such as cyclosporine) as these may impact efficacy assessments. Multivitamins, iron supplements, and folate are acceptable.
- Facial procedure (eg, blue light, chemical or laser peel, or microdermabrasion) within the past 4 weeks.
- Require or desire excessive or prolonged exposure to ultraviolet light during the study.
- Known hypersensitivity or previous allergic reaction to any of the active components of the study product.
- A significant medical history of or currently immunocompromised.
- Use of any investigational product within the past 4 weeks or currently participating in another clinical study.
- Any other condition which, in the judgment of the investigator, would put the subject at unacceptable risk for participation in the study.
- Any major illness within 30 days before study enrollment.
- Currently lives in the same household as currently enrolled subjects; is an employee of Stiefel, an investigator, or a CRO involved in the study; or is an immediate family member (eg, partner, offspring, parents) of an employee involved in the study
Trial location(s)
Location
Progressive Clinical Research
San Antonio, TX, United States, 78229
Status
Recruitment Complete
Location
Clinical Partners, LLC
Johnston, RI, United States, 02919
Status
Recruitment Complete
Location
Dermatology Specialists
Louisville, KY, United States, 40202
Status
Recruitment Complete
Location
The Laser Institute for Dermatology
Santa Monica, CA, United States, 90404
Status
Recruitment Complete
Location
Atlanta Dermatology & Vein Research Center, PC
Alpharetta, GA, United States, 30022
Status
Recruitment Complete
Location
Henry Ford Medical Center
Detroit, MI, United States, 48202
Status
Recruitment Complete
Location
Gwinnett Clinical Research Center, Inc.
Snellville, GA, United States, 30078
Status
Recruitment Complete
Location
Dermatology Associates of Rochester, PC
Rochester, NY, United States, 14623
Status
Recruitment Complete
Location
Guildford Dermatology Specialist
Surrey, BC, Canada, V3R 6A7
Status
Recruitment Complete
Location
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
Status
Recruitment Complete
Location
Suzanne Bruce and Associates, PA
Houston, TX, United States, 77056
Status
Recruitment Complete
Location
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Status
Recruitment Complete
Location
Virginia Clinical Research, Inc.
Norfolk, VA, United States, 23507
Status
Recruitment Complete
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
Completed
Actual primary completion date
2010-09-11
Actual study completion date
2010-09-11
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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