Clinical trial NCT01114841: A Study To Evaluate The Contact Sensitization Potential Of Tazarotene Foam On Skin In Healthy Volunteers
Official title: A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Contact Sensitization Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Acne Vulgaris
Keywords: Healthy Volunteer Subjects
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
Collaborators: name: GlaxoSmithKline
First posted: 2010-05-03
Enrollment: 254
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Detailed description: This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam 0.1% to induce contact sensitization following repeated exposure under maximal stress conditions in healthy adult volunteers. Approximately 240 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

All subjects will be exposed to patches containing tazarotene foam and vehicle foam. Inflammatory skin responses (eg, erythema, edema, papules) or superficial effects at patch sites will be visually assessed and scored according to the corresponding grading scales.

The study duration will be 6 weeks or 9 weeks and will consist of the following phases: 3 week Induction, 2 week Rest, and 1 week Challenge, and if indicated, a second 2 week Rest and 1 week Repeat Challenge.

Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.
* Used antihistamines, selective leukotriene receptor antagonists (eg, montelukast sodium, zafirlukast), or mast cell stabilizers (eg, cromolyn sodium or nedocromil sodium) within 4 weeks of the Day 1 visit.
* Used nonsteroidal anti-inflammatory medications within 2 weeks of the Day 1 visit.
* Currently using any medication that, in the opinion of the investigator, may affect the evaluation of the study product or place the subject at undue risk.
* Participated in a previous study of the same study product.
* Employee of the study center, contract research organization, or Stiefel who is involved in the study, or an immediate family member (eg, partner, offspring, parents, siblings or sibling's offspring) of an employee who is involved in the study.

Primary outcomes:
measure: Inflammatory skin responses
timeFrame: 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)
Secondary outcomes:
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: HillTop Research Corporation
state: Arizona
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References:
citation: 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.