A Study to Evaluate the Irritation Potential of Tazarotene Foam on Skin in Healthy Volunteers

NCT01112787 | Completed Phase 1

• 1 other identifier: 114571
• Study Type: interventional
• Target: 39
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to evaluate the irritation level of tazarotene foam after 21 days of exposure on the skin of healthy volunteers.

Conditions

Acne Vulgaris

Keywords

Healthy Volunteer Subjects

Outcome Measures

Primary Outcomes (1)

• Inflammatory skin responses

  Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.

  21 days

Study Arms (4)

Tazarotene Foam

EXPERIMENTAL

Subjects will be exposed to patches containing Tazarotene Foam 0.1%,

Drug: Tazarotene Foam

Vehicle Foam

PLACEBO COMPARATOR

Subjects will be exposed to patches containing Vehicle Foam.

Drug: Vehicle Foam

Sodium Laural Sulfate

ACTIVE COMPARATOR

Subjects will be exposed to patches containing Sodium Laural Sulfate.

Drug: Sodium Laural Sulfate

Distilled Water

PLACEBO COMPARATOR

Subjects will be exposed to patches containing Distilled Water.

Drug: Distilled Water

Interventions

Tazarotene Foam DRUG

Tazarotene Foam

Tazarotene Foam

Vehicle Foam DRUG

Vehicle Foam

Vehicle Foam

Sodium Laural Sulfate DRUG

Sodium Laural Sulfate

Sodium Laural Sulfate

Distilled Water DRUG

Distilled Water

Distilled Water

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Capable of understanding and willing to provide signed and dated written voluntary informed consent and Health Information Portability and Accountability Act (HIPAA) authorization before any protocol-specific procedures are performed.
• Male or female aged 18 to 65 years, inclusive, at time of consent.
• Able and willing to complete the study and to comply with all study instructions.
• Possess Fitzpatrick skin types I (always burns easily; never tans), II (always burns easily; tans minimally), III (burns moderately; tans gradually), or IV (rarely burns; tans with ease) that will not interfere with the evaluation of any skin responses .
• Male subjects and their partners must agree to use a medically acceptable method of contraception.
• Additional criteria for women of childbearing potential, defined as one who is biologically capable of becoming pregnant, including perimenopausal women who are less than 2 years from their last menses:
• A regular menstrual cycle before study entry (as reported by the subject).
• Negative urine pregnancy test within 2 weeks of the first application of study product.
• Sexually active females of childbearing potential participating in the study must agree to use a medically acceptable method of contraception throughout the duration of the study.
• Women who are not currently sexually active must agree to use a medically acceptable method of contraception should they become sexually active while participating in the study.

You may not qualify if:

• Female who is pregnant, trying to become pregnant, or breast feeding.
• Considered unable or unlikely to attend the necessary visits.
• History of known or suspected intolerance to tazarotene, any of the ingredients of the study products, the hypoallergenic tape, or the cotton patches.
• Participation in any patch test study within 4 weeks of the Day 1 visit.
• Inability to evaluate the skin in and around the potential patch test sites on the back due to sunburns, unevenness in skin tones, tattoos, scars, excessive hair, freckles, birthmarks, moles, or other skin damage or abnormality.
• Clinically significant skin diseases that may contraindicate participation or interfere with patch test site evaluations, including psoriasis, eczema, atopic dermatitis, acne, dysplastic nevi, or other skin pathologies, or a history of skin cancer.
• Any major illness within 4 weeks of the Day 1 visit.
• Considered immunocompromised.
• A clinically relevant history of or current evidence of abuse of alcohol or other drugs.
• Clinically relevant history or currently suffering from any disease or condition that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk. This may include respiratory (including chronic asthma requiring repetitive drug interventions), gastrointestinal, renal, hepatic, hematological, lymphatic, neurological, cardiovascular, psychiatric, musculoskeletal, genitourinary, immunological, dermatological, or connective tissue diseases or disorders.
• Received any investigational product or procedure within 4 weeks of the Day 1 visit or who is scheduled to receive an investigational product (other than the study product) or procedure during the study.
• Received allergy injections within 1 week of the Day 1 visit, or expects to receive allergy injections during study participation.
• Received immunizations within 4 weeks of the Day 1 visit.
• Used systemic or topical corticosteroids or other immunosuppressive medications within 4 weeks of the Day 1 visit.
• Used topical medications or other products (eg, self tanning products, waxing products, benzoyl peroxide, salicylic acid, or sulfur) in the areas of patch testing within 2 weeks of the Day 1 visit.

Sponsors & Collaborators

• Stiefel, a GSK Company: lead
• GlaxoSmithKline: collaborator

Study Sites (1)

HillTop Research Corporation

Scottsdale, Arizona, 85251, United States

Location

Related Links

• Results for study 114571 can be found on the GSK Clinical Study Register.
• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

MeSH Terms

Conditions

Acne Vulgaris

Condition Hierarchy (Ancestors)

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

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2010
• First Posted: April 28, 2010
• Study Start: March 26, 2010
• Primary Completion: April 26, 2010
• Study Completion: April 26, 2010
• Last Updated: June 20, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)