A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris

NCT02267746 | Completed Phase 3 Results

• 1 other identifier: WAT 14-1096
• Study Type: interventional
• Target: 893
• Locations: 2 countries
• Sites: 15

Brief Summary

The purpose of this study is to compare the safety and therapeutic equivalence of a generic tazarotene foam 0.1% and the reference listed Fabior™ (tazarotene foam, 0.1%) in the treatment of acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts

  For the purposes of study treatment and evaluation, these lesions were limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e., the lines around the nostrils and under the nostrils) and all mucus membranes.

  Mean percent change from baseline to Week 12

• Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts

  Estimates of mean percent change from baseline for non-inflammatory lesions for the Test and Reference treatment.

  Mean percent change from baseline to Week 12

Secondary Outcomes (1)

• The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment

  IGA score at Week 12 compared to baseline

Study Arms (3)

Fabior™(tazarotene)

ACTIVE COMPARATOR

Reference listed drug: Fabior™ 0.1% foam (Stiefel)

Drug: Tazarotene (Fabior™)

Tazarotene

EXPERIMENTAL

Tazarotene 0/1% foam (Actavis)

Drug: Tazarotene (Actavis)

Vehicle foam

PLACEBO COMPARATOR

Foam vehicle of the test product (Actavis)

Drug: Vehicle foam

Interventions

Tazarotene (Fabior™) DRUG

Fabior™(tazarotene)

Tazarotene (Actavis) DRUG

Tazarotene

Vehicle foam DRUG

Vehicle foam

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Healthy male or nonpregnant female aged ≥ 12 and ≤ 40 years with a clinical diagnosis of acne vulgaris.
• Informed Consent/Assent: Subjects ages 12 to 17 years inclusive must have provided IRB approved written assent; this written assent must be accompanied by an IRB approved written informed consent from the Subject's legally acceptable representative (i.e., parent or guardian). In addition, all Subjects or their legally acceptable representatives (i.e., parent or guardian) must sign a HIPAA authorization.
• Subjects must have a minimum ≥ 30 non-inflammatory lesions (i.e., open and closed comedones) AND ≥ 25 inflammatory lesions (i.e., papules and pustules) AND no cystic lesions and only up to 1 facial nodular lesion (less than or equal to 5 mm) on the face. For the purposes of study treatment and evaluation, these lesions should be limited to the facial treatment area excluding the eyes, the lips, and angles of the nose (i.e. the lines around the nostrils and under the nostrils) and all mucus membranes. Subjects may have acne lesions on other areas of the body which will also be excluded from the count, treatment, and the Investigator's Global Assessment (IGA) evaluation (e.g., on the back, chest and arms).
• Subjects must have a severity grade 3, or 4 as per the Investigator's Global Assessment (IGA) (Section 6.2).
• Subjects must be willing to refrain from using all other topical acne medications or antibiotics during the 12-week treatment period for acne vulgaris, other than the Investigational Product.
• Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must have a negative urine pregnancy test (with sensitivity down to at least 50mIU/ml hCG) within 2 weeks prior to baseline.
• Female Subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 1 year), must be willing to use an acceptable form of birth control from the day of the first dose administration.. For the purpose of this study the following are considered acceptable methods of birth control: oral or injectable contraceptives, contraceptive patches, Depo-Provera® (stabilized for at least 3 months); NuvaRing® (vaginal contraceptive); Implanon™ (contraceptive implant) double barrier methods (e.g. condom and spermicide); IUD, or abstinence with a 2nd acceptable method of birth control should the Subject become sexually active. A sterile sexual partner is NOT considered an adequate form of birth control.
• All male Subjects must agree to use accepted methods of birth control with their partners, from the day of the first dose administration. Abstinence is an acceptable method of birth control for males.
• Subjects must be willing and able to understand and comply with the requirements of the protocol, including attendance at the required study visits.
• Subjects who use make-up must have used the same brands/types of make-up for a minimum period of 14 days prior to study entry and must agree to not change make-up brand/type or frequency of use throughout the study.

You may not qualify if:

• Female Subjects who are pregnant, nursing or planning to become pregnant during study participation.
• Subjects with a history of hypersensitivity or allergy to tazarotene and its excipients, and/or any of the study medication ingredients.
• Subjects with the presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris. Such conditions include, but are not limited to the following: auto immune disease, rosacea; seborrheic dermatitis; perioral dermatitis; corticosteroid-induced acne; carcinoid syndrome; mastocytosis; acneform eruptions caused by make-up, medication, facial psoriasis and facial eczema, squamous cell carcinoma, steroid folliculitis, or bacterial folliculitis).
• Subjects who have acne congoblata, acne fulminans, and secondary acne (e.g., chloracne and drug induced acne) will be excluded from participation.
• Subjects with excessive facial hair (e.g. beards, sideburns, moustaches, etc.) that would interfere with diagnosis or assessment of acne vulgaris.
• Subjects who have used any of the following within 6 months prior to baseline or use during the study:
• oral retinoids (e.g. Accutane®)
• therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• Subjects who have used estrogens or oral contraceptives for less than 3 months prior to baseline; use of such therapy must remain constant throughout the study.
• Subjects who use androgen receptor blockers (such as spironolactone or flutamide) will be excluded from study participation.
• Subjects who have had cosmetic procedures (e.g., facials, wax depilation) which may affect the efficacy and safety profile of the investigational product within 14 days prior to study entry. Cosmetic procedures and facials are prohibited throughout the study.
• Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline.
• Subjects who have had laser therapy, electrodessication and phototherapy (e.g., ClearLight®) to the facial area within 180 days prior to study entry.
• Subjects who have used any of the following procedures on the face within 1 month prior to baseline or during the study:
• cryodestruction or chemodestruction,

Sponsors & Collaborators

• Actavis Inc.: lead

Study Sites (15)

Unknown Facility

Encino, California, 91436, United States

Location

Center for Dermatology Clinical Research

Fremont, California, 94538, United States

Location

Moore Clinical Research

Brandon, Florida, 33511, United States

Location

LCC Medical Research Institute

Miami, Florida, 33126, United States

Location

International Dermatology Research

Miami, Florida, 33144, United States

Location

FXM Research Corp

Miami, Florida, 33175, United States

Location

FXM Research Miramar

Miramar, Florida, 33027, United States

Location

Moore Clinical Research

Tampa, Florida, 33609, United States

Location

Moore Clinical Research

Tampa, Florida, 33618, United States

Location

Atlantic Clinical Research Collaborative

Wellington, Florida, 33414, United States

Location

Omega Medical Research

Warwick, Rhode Island, 02886, United States

Location

Research Across America

Dallas, Texas, 75234, United States

Location

Research Across America

Plano, Texas, 75093, United States

Location

Dermatology Research Center

Salt Lake City, Utah, 84117, United States

Location

FXM International

Belize City, Belize

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

tazarotene

Condition Hierarchy (Ancestors)

Acneiform Eruptions; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases

Results Point of Contact

• Title: Director, CE Studies
• Organization: Teva Pharmaceuticals USA, Inc.

USMedinfo@tevapharm.com

1-888-483-8279

Study Officials

• Keri Winkler

  Akesis, LLC

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 14, 2014
• First Posted: October 17, 2014
• Study Start: June 1, 2014
• Primary Completion: September 1, 2014
• Study Completion: September 1, 2014
• Last Updated: June 12, 2020
• Results First Posted: May 11, 2020

Record last verified: 2020-05

Locations

BE (1); US (14)