A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers

NCT01114841 | Completed Phase 1

• 1 other identifier: 114572
• Study Type: interventional
• Target: 254
• Locations: 1 country
• Sites: 1

Brief Summary

This study will assess the potential of tazarotene foam to cause sensitization during a 48 hour challenge following 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

  Induction: Baseline-Week 3 - every 48 to 72 hours; Challenge: Week 6 - after 48 hours, then again at 24, 48, and 72 hours; if indicated a second challenge: Week 9 after 48 hours, then at 24, 48, and 72 hours following patch removal)

Study Arms (2)

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

Interventions

Tazarotene Foam DRUG

Patches containing Tazarotene Foam 0.1% will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.

Tazarotene Foam

Vehicle Foam DRUG

Patches containing Vehicle Foam will be applied to randomized sites on the subject's back and will be assessed 3 times per week for 3 weeks. Patches will be removed and evaluated every 48 to 72 hours. There will be a 10-14 day rest period followed by a single 48-hour patch application (challenge). These patches will then be evaluated at 24, 48, and 72 hours. There may be a second rest period and a second 48-hour patch application and evaluation, if required.

Vehicle Foam

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 (Fitzpatrick 1988). Determination of skin types will be based on sunburn and tanning histories, as well as subjects' opinions of their responses to the first 30 to 45 minutes of sun exposure.
• 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. Acceptable contraceptive methods include the following:
• Hormonal contraception, including oral, injectable, or implantable methods started at least 2 months prior to screening. If hormonal contraception was started less than 2 months prior to screening, then a form of nonhormonal contraception should be added until the third continuous month of hormonal contraception has been completed.
• Two forms of reliable nonhormonal contraception, to include the use of either an intrauterine device plus a reliable barrier method or 2 reliable barrier methods. Reliable barrier methods include condoms or diaphragms. A cervical cap is also a reliable barrier method, provided that the female subject has never given birth vaginally. The combined use of a condom and spermicide constitute 2 forms of acceptable nonhormonal contraception, provided that they are both used properly. The use of spermicide alone and the improper use of condoms are inferior methods of contraception. Subjects with surgical sterilization, including tubal sterilization or partner's vasectomy, must use a form of nonhormonal contraception. A barrier method or sterilization plus spermicide is acceptable.
• 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 Publications (1)

• Berg JE, Bowman JP, Saenz AB. Cumulative irritation potential and contact sensitization potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Oct;90(4):206-11.

  PMID: 23259209 BACKGROUND

Related Links

• Results for study 114572 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: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 29, 2010
• First Posted: May 3, 2010
• Study Start: March 31, 2010
• Primary Completion: June 26, 2010
• Study Completion: June 26, 2010
• Last Updated: June 14, 2017

Record last verified: 2017-06

Data Sharing

• IPD Sharing: Will share

Locations

US (1)