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

This study has been completed.
Sponsor:
Collaborator:
GlaxoSmithKline
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT01017120
First received: November 19, 2009
Last updated: May 31, 2012
Last verified: May 2012
  Purpose

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


Condition Intervention Phase
Acne Vulgaris
Drug: Tazarotene Foam
Drug: Vehicle Foam
Phase 3

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

Resource links provided by NLM:


Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Absolute Change in Lesion Counts (LCs) From Baseline to Week 12 [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Minimum 2-grade (G) Improvement in the Investigator Static Global Assessment (ISGA) Score From Baseline at Week 12 [ Time Frame: Baseline (Week 0/Day 1) and Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With an ISGA Score of 0 or 1 at Week 12 [ Time Frame: Week 12 ] [ Designated as safety issue: No ]
    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.


Secondary Outcome Measures:
  • Percent Change in LC From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • Absolute Change From Baseline in LC at Weeks 2, 4, and 8 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    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.

  • Time to a 50 Percent Reduction in Total Lesion Counts (TLC) [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Minimum 2 G Improvement in ISGA Score at Weeks 2, 4, and 8 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With an ISGA Score of 0 or 1 at Weeks 2, 4, and 8 [ Time Frame: Weeks 2, 4, and 8 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With a Subject's Global Assessment (SGA) Score of 0 or 1 at Weeks 2, 4, 8, and 12 [ Time Frame: Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • Absolute Change in Papule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    A papule is a circumscribed, solid elevation of the skin with no visible fluid. Change from basline in papule count at Weeks 2, 4, 8, and 12 was calculated as the papule count at Week 2/4/8/12 minus the papule count at Baseline.

  • Absolute Change in Pustule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    A pustule is a small elevation of the skin containing cloudy or purulent material usually consisting of necrotic inflammatory cells. Change from basline in pustule count at Weeks 2, 4, 8, and 12 was calculated as the pustule count at Week 2/4/8/12 minus the pustule count at Baseline.

  • Absolute Change in Nodule Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    A nodule is a slightly elevated lesion on or in the skin. Change from basline in nodule count at Weeks 2, 4, 8, and 12 was calculated as the nodule count at Week 2/4/8/12 value (s) minus the nodule count at Baseline.

  • Absolute Change in Open Comedone Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    An open comedone is a yellow or blackish bump or plug on the skin. Change from Baseline in open comedone count at Weeks 2, 4, 8, and 12 was calculated as the open comedone count at Week 2/4/8/12 minus the open comedone count at Baseline.

  • Absolute Change in Closed Comedone Count From Baseline at Weeks 2, 4, 8, and 12 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    A closed comedone is a whitehead. Change from basline in closed comedone count at Weeks 2, 4, 8, and 12 was calculated as the closed comedone count at Week 2/4/8/12 minus the closed comedone count at Baseline.

  • 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 [ Time Frame: Baseline (Week 0/Day 1); Weeks 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • 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 [ Time Frame: Baseline (Week 0/Day 1); Week 2, 4, 8, and 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Local Tolerability Assessment for Erythema as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Local Tolerability Assessment for Drying as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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 dryness reported at any time during treatment.

  • Number of Participants With the Indicated Local Tolerability Assessment for Peeling as Evaluated by the Investigator [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Local Tolerability Assessment for Itching as Evaluated by the Participants [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With the Indicated Local Tolerability Assessment for Burning/Stinging as Evaluated by the Participants [ Time Frame: Baseline (Week 0/Day 1) to Week 12 ] [ Designated as safety issue: No ]
    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.


Enrollment: 742
Study Start Date: October 2009
Study Completion Date: December 2010
Primary Completion Date: November 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Tazarotene foam, 0.1%
Drug: Tazarotene Foam
Tazarotene foam once a day application to the face
Placebo Comparator: 2
Vehicle Foam
Drug: Vehicle Foam
Vehicle Foam once a day application to the face

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

Ages Eligible for Study:   12 Years to 45 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01017120

Locations
United States, California
The Laser Institute for Dermatology
Santa Monica, California, United States, 90404
United States, Florida
FXM Research Corporation
Miami, Florida, United States, 33175
United States, Georgia
Atlanta Dermatology & Vein Research Center, PC
Alpharetta, Georgia, United States, 30022
Gwinnett Clinical Research Center, Inc.
Snellville, Georgia, United States, 30078
United States, Indiana
Hudson Dermatology
Evansville, Indiana, United States, 47714
United States, Kentucky
Dermatology Specialists
Louisville, Kentucky, United States, 40202
United States, Michigan
Henry Ford Medical Center
Detroit, Michigan, United States, 48202
Somerset Skin Centre
Troy, Michigan, United States, 48084
United States, Nebraska
Skin Specialists, P.C.
Omaha, Nebraska, United States, 68144
United States, New York
Dermatology Associates of Rochester, PC
Rochester, New York, United States, 14623
United States, Rhode Island
Clinical Partners, LLC
Johnston, Rhode Island, United States, 02919
United States, Texas
Suzanne Bruce and Associates, PA
Houston, Texas, United States, 77056
Progressive Clinical Research
San Antonio, Texas, United States, 78229
United States, Virginia
Virginia Clinical Research, Inc.
Norfolk, Virginia, United States, 23507
Canada, British Columbia
Guildford Dermatology Specialist
Surrey, British Columbia, Canada, V3R 6A7
Canada, Manitoba
Dermadvances Research
Winnipeg, Manitoba, Canada, R3C 1R4
Canada, Ontario
Lynderm Research, Inc.
Markham, Ontario, Canada, L3P 1A8
North Bay Dermatology Centre
North Bay, Ontario, Canada, P1B3Z7
Sponsors and Collaborators
Stiefel, a GSK Company
GlaxoSmithKline
Investigators
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

No publications provided

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT01017120     History of Changes
Other Study ID Numbers: 114576, W0260-302
Study First Received: November 19, 2009
Results First Received: May 31, 2012
Last Updated: May 31, 2012
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
Acne

Additional relevant MeSH terms:
Acne Vulgaris
Acneiform Eruptions
Skin Diseases
Facial Dermatoses
Sebaceous Gland Diseases
Tazarotene
Keratolytic Agents
Dermatologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 24, 2014