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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT02267746
• Date of registration: 14/10/2014
• Prospective Registration: No
• Primary sponsor: Actavis Inc.
• Public title: A Study To Evaluate The Safety And Therapeutic Equivalence of Tazarotene Foam 0.1% in Subjects With Acne Vulgaris
• Scientific title: A Multicenter, Double-Blind, Randomized, Parallel-Group, Vehicle-Controlled Study to Evaluate the Safety and Therapeutic Equivalence of a Generic Tazarotene Foam 0.1%(Actavis) and the Reference Listed Fabior™(Tazarotene Foam, 0.1%) (Stiefel Laboratories, Inc.) in Treatment of Subjects With Acne Vulgaris
• Date of first enrolment: June 2014
• Target sample size: 893
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT02267746
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 3

Countries of recruitment

Belize, United States

Contacts

• Name: Keri Winkler
• Affiliation: Akesis, LLC

Key inclusion & exclusion criteria

Inclusion Criteria:

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.

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Exclusion Criteria:

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:

1. oral retinoids (e.g. Accutane®)

2. 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:

1. cryodestruction or chemodestruction,

2. dermabrasion,

3. photodynamic therapy,

4. acne surgery,

5. intralesional steroids, or

6. X-ray therapy.

Subjects who have used any of the following treatments within 1 month prior to baseline or
during the study:

1. systemic corticosteroids (including intranasal and inhaled corticosteroids)

2. systemic antibiotics,

3. systemic treatment for acne vulgaris (other than oral retinoids which need a 6-month
washout), or

4. systemic anti-inflammatory agents.

Subjects who have used any of the following treatments within 14 days prior to baseline or
during the study:

1. topical steroids,

2. topical retinoids including over-the-counter preparations,

3. a-hydroxy/glycolic acid

4. topical anti-inflammatory agents, or

5. topical antibiotics.

Subjects who have started hormonal therapy or changed the dosage of their hormonal therapy
within 3 months prior to baseline will be excluded from study participation. The dosage and
frequency of use of any hormonal therapy started greater than 3 months prior to baseline
must remain unchanged throughout the study (Visit 1 through Visit 4). Hormonal treatments
include, but are not limited to, estrogenic and progestational age


Age minimum: 12 Years
Age maximum: 40 Years
Gender: All

Health Condition(s) or Problem(s) studied

Acne Vulgaris

Intervention(s)

Drug: Tazarotene (Actavis)

Drug: Vehicle foam

Drug: Tazarotene (Fabior™)

Primary Outcome(s)

Percent Change in the Non-inflammatory (Open and Closed Comedones) Lesion Counts [Time Frame: Mean percent change from baseline to Week 12]

Percent Change in the Inflammatory (Papules and Pustules) Lesion Counts [Time Frame: Mean percent change from baseline to Week 12]

Secondary Outcome(s)

The Proportion of Subjects With an IGA Score That is at Least 2 Grades Less Than the Baseline Assessment [Time Frame: IGA score at Week 12 compared to baseline]

Secondary ID(s)

WAT 14-1096

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 11/05/2020
• URL: https://clinicaltrials.gov/ct2/show/results/NCT02267746