Clinical trial NCT01017120: A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Acne Vulgaris
Keywords: Acne
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2009-11-20
Enrollment: 742
Sex: ALL
Minimum age (years): 12
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

Detailed description: A multicenter, randomized, double-blind, vehicle-controlled, parallel-group study comparing tazarotene foam with vehicle foam in subjects with acne vulgaris. Approximately 742 subjects will be enrolled and randomized to 1 of the 2 study product groups in a 1:1 ratio (tazarotene foam: vehicle foam). Subjects will apply tazarotene foam or vehicle foam to the entire face once daily for 12 weeks; study visits will occur at baseline (week 0/day 1) and at weeks 2, 4, 8, and 12.

Eligibility 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:

  1. Between 25 and 50 facial inflammatory lesions and no more than 1 facial nodular lesion (\<5mm), with NO cystic lesions.
  2. Between 30 and 125 facial noninflammatory lesions, excluding nasal lesions. - Regular menstrual cycle prior to study entry for females of childbearing potential.
* Negative urine pregnancy test 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.

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

Primary outcomes:
measure: Absolute Change in Lesion Counts (LCs) From Baseline to Week 12
timeFrame: Baseline (Week 0/Day 1) and Week 12
measure: 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
measure: Number of Participants With an ISGA Score of 0 or 1 at Week 12
timeFrame: Week 12
Secondary outcomes:
measure: 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
measure: Absolute Change From Baseline in LC at Weeks 2, 4, and 8
timeFrame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8
measure: Time to a 50 Percent Reduction in Total Lesion Counts (TLC)
timeFrame: Baseline (Week 0/Day 1) to Week 12
measure: 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
measure: Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8
timeFrame: Weeks 2, 4, and 8
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
measure: 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
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: The Laser Institute for Dermatology
state: California
city: Miami
country: United States
facility: FXM Research Corporation
state: Florida
city: Alpharetta
country: United States
facility: Atlanta Dermatology & Vein Research Center, PC
state: Georgia
city: Snellville
country: United States
facility: Gwinnett Clinical Research Center, Inc.
state: Georgia
city: Evansville
country: United States
facility: Hudson Dermatology
state: Indiana
city: Louisville
country: United States
facility: Dermatology Specialists
state: Kentucky
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Troy
country: United States
facility: Somerset Skin Centre
state: Michigan
city: Omaha
country: United States
facility: Skin Specialists, P.C.
state: Nebraska
city: Rochester
country: United States
facility: Dermatology Associates of Rochester, PC
state: New York
city: Johnston
country: United States
facility: Clinical Partners, LLC
state: Rhode Island
city: Houston
country: United States
facility: Suzanne Bruce and Associates, PA
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Norfolk
country: United States
facility: Virginia Clinical Research, Inc.
state: Virginia
city: Surrey
country: Canada
facility: Guildford Dermatology Specialist
state: British Columbia
city: Winnipeg
country: Canada
facility: Dermadvances Research
state: Manitoba
city: Markham
country: Canada
facility: Lynderm Research, Inc.
state: Ontario
city: North Bay
country: Canada
facility: North Bay Dermatology Centre
state: Ontario
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: Feldman SR, Werner CP, Alio Saenz AB. 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 Apr;12(4):438-46.