Generic Tazarotene Cream, 0.1% in the Treatment of Acne Vulgaris

NCT02160678 | Completed Phase 3

• 1 other identifier: SYM 2014-01
• Study Type: interventional
• Target: 1,741
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the safety and efficacy profiles of Tazarotene Cream, 0.1 % to the reference listed drug Tazorac® (tazarotene) Cream, 0.1 % in order to demonstrate bioequivalence, and to demonstrate superiority of the 2 active creams over that of the cream vehicle (placebo) in the treatment of acne vulgaris.

Conditions

Acne Vulgaris

Outcome Measures

Primary Outcomes (2)

• Evaluation of equivalence of the test product to the reference product

  The primary evaluation of equivalence will be through 2-sided 90% confidence intervals (CIs) about the ratio in mean percent reduction from baseline to Visit 4/Week 12 in the number of inflammatory and non-inflammatory lesions, respectively, of the test product to the reference product. These evaluations are based on a normal distribution adjusted for the effects of treatment group and site.

  Week 12

• Evaluation of superiority

  The primary evaluation of superiority will be conducted using an analysis of variance (ANOVA) model on the mean percent reduction in inflammatory and non-inflammatory lesions, respectively, with treatment and site as fixed effects. Contrasts will be performed to compare each active treatment with the vehicle cream.

  Week 12

Secondary Outcomes (1)

• Proportion of subjects with a clinical response of "success"

  Week 12

Study Arms (3)

Tazarotene Cream, 0.1 %

ACTIVE COMPARATOR

Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product

Drug: Tazarotene Cream, 0.1 %

Tazorac Cream, 0.1%

OTHER

Tazorac Cream, 0.1% (Allergan, Inc.) - reference product

Drug: Tazorac Cream, 0.1%

Vehicle

PLACEBO COMPARATOR

Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle

Drug: Vehicle

Interventions

Vehicle DRUG

Cream Vehicle (placebo) (G \& W Laboratories, Inc.)- vehicle

Also known as: Placebo

Vehicle

Tazarotene Cream, 0.1 % DRUG

Tazarotene Cream, 0.1 % (G \& W Laboratories, Inc.) - test product

Also known as: Active

Tazarotene Cream, 0.1 %

Tazorac Cream, 0.1% DRUG

Tazorac Cream, 0.1% (Allergan, Inc.) - reference product

Also known as: Reference Listed Drug

Tazorac Cream, 0.1%

Eligibility Criteria

• Age: 12 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Be willing and able to provide written informed consent/assent for the study.
• Be a healthy male or non-pregnant female aged ≥ 12 and ≤ 40 years of age, inclusive.
• Have a clinical diagnosis of acne vulgaris, defined as having all of the following:
• On the face, ≥ 20 inflammatory lesions (papules and pustules)
• On the face, ≥ 25 non-inflammatory lesions (open and closed comedones)
• On the face, ≤ 2 nodulocystic lesions (nodules and cysts)
• Baseline IGA of acne severity grade 2, 3, or 4
• Be in general good health and free from any clinically significant disease other than acne vulgaris that might interfere with the study evaluations.
• Be willing to refrain from use of all other topical acne medications or antibiotics during the 12-week treatment period.
• Be willing and able to understand and comply with the requirements of the study, apply the study medication as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
• Female subjects of childbearing potential (excluding women who are surgically sterilized or postmenopausal for at least 2 years) must have a negative urine pregnancy test (with a minimum sensitivity of at least 50 mIU/mL for human chorionic gonadotropin \[hCG\], begin treatment during a normal menstrual period and must agree to use a medically accepted method of contraception during the study. The following are considered acceptable methods of birth control for the purpose of this study: oral contraceptives, contraceptive patches, contraceptive implant, vaginal contraceptive, double barrier methods (e.g., condom and spermicide), contraceptive injection (Depo-Provera®), intrauterine device (IUD), hormonal IUD (Mirena®), and abstinence with a documented second acceptable method of birth control if the subject becomes sexually active. Subjects entering the study who are on hormonal contraceptives must have been on the method for at least 90 days prior to the study and continue the method for the duration of the study. Subjects who had used hormonal contraception and stopped must have stopped no less than 90 days prior to Visit 1/Day 1.
• Be willing to limit sun exposure overall, maintain a reasonably constant exposure, and avoid use of tanning booths or other UV light sources during participation in the study.

You may not qualify if:

• Females who are pregnant, breast feeding, planning a pregnancy, or who do not agree to use an acceptable form of birth control during the study.
• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneiform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Currently has active cystic acne, acne conglobata, acne fulminans, secondary acne, or severe acne requiring more than topical treatment.
• Currently has facial sunburn.
• Received initial administrations of estrogens or oral contraceptives \< 3 months (90 days) prior to baseline (Visit 1/Day 1), or discontinued estrogens or oral contraceptives \< 3 months (90 days) prior to baseline. Use of such therapy must remain constant during the study.
• Use of any treatment listing in Table 8.1 more recently than the indicated washout period prior to baseline (Visit 1/Day 1).
• Need or intent to continue to use any treatment listed in Table 8.1 during the current study.

Sponsors & Collaborators

• G & W Laboratories Inc.: lead

Study Sites (1)

Altman Dermatology Associates

Arlington Hts., Illinois, 60005, United States

Location

MeSH Terms

Conditions

Acne Vulgaris

Interventions

Exercise

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena

Study Officials

• Michael Bukhalo, MD

  Altman Dermatology Associates

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: March 19, 2014
• First Posted: June 11, 2014
• Study Start: May 1, 2014
• Primary Completion: July 1, 2015
• Study Completion: July 1, 2015
• Last Updated: November 3, 2016

Record last verified: 2016-11

Locations

US (1)