A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne - W0260-301

Acne Vulgaris Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01017146
• Other study ID #: 114575
• Secondary ID: W0260-301
• Status: Completed
• Phase: Phase 3
• First received: November 19, 2009
• Last updated: May 31, 2012
• Start date: October 2009
• Est. completion date: November 2010

Study information

• Verified date: May 2012
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 744
• Est. completion date: November 2010
• Est. primary completion date: November 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 12 Years to 45 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acne Vulgaris

Intervention

Drug:
• Tazarotene foam
Tazarotene foam once a day application to the face
• Vehicle Foam
Vehicle Foam once a day application to the face

Locations

Country	Name	City	State
Canada	Ultranova Skincare	Barrie	Ontario
Canada	Dermatrials Research	Hamilton	Ontario
Canada	Nexus Clinical Research	St. John's
United States	Academic Dermatology Associates	Albuquerque	New Mexico
United States	DermResearch, Inc.	Austin	Texas
United States	The Dermatology Research of Cincinnati	Cincinnati	Ohio
United States	Group Health Associates	Cincinnatti	Ohio
United States	J & S Studies, Inc.	College Station	Texas
United States	Dermatology Treatment & Research Center	Dallas	Texas
United States	Cherry Creek Research, Inc.	Denver	Colorado
United States	Minnesota Clinical Study Center	Fridley	Minnesota
United States	Dermatology Consulting Services	High Point	North Carolina
United States	Dawes Fretzin Clinical Research Group, LLC	Indianapolis	Indiana
United States	The Skin Wellness Center, PC	Knoxville	Tennessee
United States	Cosmetic Medicine & Treatment Research Insttitute, Inc.	Miami Beach	Florida
United States	Aurora Advanced Healthcare, Inc. Clinical Research Center	Milwaukee	Wisconsin
United States	Dermatology Research Associates, Inc.	Nashville	Tennessee
United States	Oregon Dermatology and Research Center	Portland	Oregon
United States	Haber Dermatology & Cosmetic Surgery, Inc.	South Euclid	Ohio
United States	DermResearch Center of New York, Inc.	Stony Brook	New York
United States	Wake Forest University Health Sciences	Winston Salem	North Carolina
United States	Yardley Dermatology Associates	Yardley	Pennsylvania

Sponsors (2)

Lead Sponsor	Collaborator
Stiefel, a GSK Company	GlaxoSmithKline

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Absolute Change in Lesion Counts (LCs) From Baseline to Week 12	LC: count of all inflammatory lesions (ILs, i.e., papules, pustules, and nodules) and non-inflammatory lesions (NILs, i.e., open and closed comedones) at Baseline and at Week 12. Total lesions (TLs) were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at Baseline.	Baseline (Week 0/Day 1) and Week 12	No
Primary	Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.	Baseline (Week 0/Day 1) and Week 12	No
Primary	Number of Participants With an ISGA Score of 0 or 1 at Week 12	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.	Week 12	No
Secondary	Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12	LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Percent change from Baseline in LC at Weeks 2, 4, 8, and12 was calculated as the (Week 2/4/8/12 value minus the baseline value divided by baseline value) x 100.	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12	No
Secondary	Absolute Change From Baseline in LC at Weeks 2, 4, and 8	LC: count of all ILs (i.e., papules, pustules, and nodules) and NILs (i.e., open and closed comedones) at Baseline and at Week 12. TLs were calculated as the sum of ILs and NILs. LC was confined to the face (including forehead, nose, checks, and chin). Change from Baseline at Week 12 was calculated as the value at Week 12 minus the value at baseline. Calculation was based on last observation carried forward (LOCF) imputation method for missing data.	Baseline (Week 0/Day 1); Weeks 2, 4, and 8	No
Secondary	Time to a 50 Percent Reduction in Total Lesion Counts (TLC)	Time to a 50 percent reduction in TLC (sum of ILs and NILs) was the time difference between Baseline and the time to 50 percent reduction in LC. Participants who did not have a >=50 percent reduction from Baseline in TLC during the study were censored at their last visit date.	Baseline (Week 0/Day 1) to Week 12	No
Secondary	Number of Participants With a Minimum 2-grade Improvement in ISGA Score at Weeks 2, 4, and 8	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.	Baseline (Week 0/Day 1); Weeks 2, 4, and 8	No
Secondary	Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8	Investigators evaluated the acne severity (S) of the participants' face using the ISGA scale, ranging from 0 to 5: 0=clear skin with no ILs or NILs; 1=almost clear: rare NIL with no more than rare papules; 2=mild S: >G 1, some NILs with no more than a few ILs (papules/pustules only, no nodular lesions [NLs]); 3=moderate S: >G 2, up to many NILs and may have some ILs, but no more than one small NL; 4=severe: greater than G 3, up to many NILs and ILs, but no more than a few NLs; 5=very severe: many NILs and ILs and more than a few NLs, may have cystic lesions.	Weeks 2, 4, and 8	No
Secondary	Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12	An SGA of the facial skin, excluding the scalp, was performed by participants using a rating scale of 0 to 4: 0=face is basically free of acne, with only an occasional blackhead (Bh) and/or whitehead (Wh); 1=face has several Bhs and/or Whs and small pimples (P), but there are no tender deep-seated bumps or cysts (DSBCs); 2=face has several to many Bhs and/or Whs and small- to medium-sized P, and may have one DSBC; 3=face has many Bhs and/or Whs, many medium- to large-sized P, and perhaps a few DSBCs; 4=face has Bhs and/or Whs, and several to many medium- to large-sized Ps and DSBCs dominate.	Weeks 2, 4, 8, and 12	No
Secondary	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	The DLQI was used to measure how much the participants' skin problem had affected their life over the last week. The DLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-5=small effect on the participant's life; 6-10=moderate effect on the participant's life; 11-20=very large effect on the participant's life; 21-30=extremely large effect on the participant's life. A lower score on the DLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12	No
Secondary	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	The CDLQI was used to measure how much the participants' skin problem had affected their life over the last week. The CDLQI total score ranges from 0 to 30: 0-1=no effect at all on the participant's life; 2-6=small effect on the participant's life; 7-12=moderate effect on the participant's life; 13-18=very large effect on the participant's life; 19-30=extremely large effect on the participant's life. A lower score on the CDLQI indicates increased quality of life; therefore, negative changes from Baseline indicate improvements.	Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12	No
Secondary	Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator	Erythema is a skin condition characterized by redness or rash. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no redness); G1=slight (faint red or pink coloration, barely perceptible); G2=mild (light red or pink coloration); G3=moderate (medium red coloration); G4=severe (beet red coloration). Maximum During Treatment is defined as the maximum severity of erythema reported at any time during treatment.	Baseline (Week 0/Day 1) to Week 12	No
Secondary	Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator	Dryness: skin epidermis that lacks moisture/sebum. Local tolerability assessments were performed by the Investigator at each study visit and were graded based on severity as G0 to G4. G0=absent (none); G1=slight (barely perceptible dryness with no flakes or fissure formation); G2=mild (easily perceptible dryness with no flakes or fissure formation); G3=moderate (easily noted dryness and flakes but no fissure formation); G4=severe (easily noted dryness with flakes and fissure formation). Maximum During Treatment is defined as the maximum severity of drying reported at any time during treatment.	Baseline (Week 0/Day 1) to Week 12	No
Secondary	Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator	Peeling skin: damage to and loss of the upper layer of skin (epidermis). Local tolerability assessments for peeling were performed by the Investigator at each study visit and were graded based on severity as G0 to G4: G0=absent (no peeling); G1=slight (mild localized peeling); G2=mild (mild and diffuse peeling); G3=moderate (moderate and diffuse peeling); G4=severe (moderate to prominent, dense peeling). Maximum During Treatment is defined as the maximum severity of peeling reported at any time during treatment.	Baseline (Week 0/Day 1) to Week 12	No
Secondary	Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants	Itching is a sensation that causes the desire or reflex to scratch. Local tolerability assessments for itching were performed by the participant at each study visit and were graded based on severity as G0 to G3. G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of itching reported at any time during treatment.	Baseline (Week 0/Day 1) to Week 12	No
Secondary	Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants	Burning/stinging is a pain and burning sensation. Local tolerability assessments were performed by the participant at each study visit based on severity as G0 to G3: G0=none; G1=slight; G2=moderate; G3=strong. Maximum During Treatment is defined as the maximum severity of burning/stinging reported at any time during treatment.	Baseline (Week 0/Day 1) to Week 12	No