A Study to Evaluate the Potential of Tazarotene Foam to Cause an Allergic Reaction When Applied to the Skin and Exposed to Light on Healthy Volunteers.
A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Photoallergic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers
1 other identifier
interventional
59
1 country
1
Brief Summary
The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a photoallergic reaction when exposed to UV and VIS light on skin of healthy volunteers.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_1
Started Jun 2010
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
May 5, 2010
CompletedFirst Posted
Study publicly available on registry
May 7, 2010
CompletedStudy Start
First participant enrolled
June 14, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 26, 2010
CompletedStudy Completion
Last participant's last visit for all outcomes
June 26, 2010
CompletedJune 14, 2017
June 1, 2017
12 days
May 5, 2010
June 12, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Inflammatory skin responses
Patch site evaluations for signs of inflammatory skin responses and superficial effect
54 days
Study Arms (9)
Tazarotene Foam without irradiation
EXPERIMENTALSubjects will be exposed to Tazarotene Foam Patch without irradiation
Tazarotene Foam with UVA and UVB irradiation
EXPERIMENTALSubjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation
Tazarotene Foam & UVA/UVB/visible light
EXPERIMENTALSubjects will be exposed to Tazarotene Foam Patch with UVA and UVB and visible light irradiation
Vehicle Foam without irradiation,
PLACEBO COMPARATORSubjects will be exposed to Vehicle Foam Patch without irradiation
Vehicle Foam with UVA and UVB irradiation
PLACEBO COMPARATORSubjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation
Vehicle Foam with UVA & UVB visible light irradiation
PLACEBO COMPARATORSubjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation
Blank patch without irradiation
SHAM COMPARATORSubjects will be exposed to blank patch without irradiation,
Blank patch with UVA and UVB irradiation
SHAM COMPARATORSubjects will be exposed to blank patch with UVA and UVB irradiation
Blank Patch with UVA & UVB visible light irradiation
SHAM COMPARATORSubjects will be exposed to Blank Patch with UVA and UVB and visible light irradiation
Interventions
There are 2 phases in this study. The induction phase will include 6 days of patch application to the subject's back. Patches will be removed daily and irradiated. Patch applications will be placed on the same sites, unless a strong reaction is observed. The induction phase will be followed by a rest period followed by the Challenge Phase which consists of a 24-hr application of 3 sets of 3 patches (Set C, Set D, and Set E) applied to naïve sites on the subject's back. Each set of patches will consist of a tazarotene foam patch, a vehicle foam patch, and a blank patch. After 24 hrs, Set D patch sites will be evaluated and irradiated with UVA/UVB light. Set C patch sites will be evaluated and irradiated with UVA, UVB light and visible light. Set E patch sites will be evaluated \& will serve as nonirradiated controls. Patch sites will be evaluated 1 hr after patch removal and during follow up visits at 24 hrs, 48 hrs, and 72 hrs after removal of the final patch in Set E.
Eligibility Criteria
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), or III (burns moderately; tans gradually) 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 Screening Visit 1.
- 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.
- A history of severe reactions from exposure to sunlight, including previous experience with photoallergy, solar urticaria, polymorphous light eruptions, or other photo exacerbated systemic diseases.
- Any major illness within 4 weeks of Screening Visit 1.
- 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.
- Used photosensitizing medications (prescription, nonprescription, or herbal) or a known photosensitizing material within 2 weeks of Screening Visit 1.
- Received any investigational product or procedure within 4 weeks of Screening Visit 1 or is scheduled to receive an investigational product (other than the study product) or procedure during the study.
- Received allergy injections within 1 week of Screening Visit 1, or expects to receive allergy injections during study participation.
- Received immunizations within 4 weeks of Screening Visit 1.
- +7 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Stiefel, a GSK Companylead
- GlaxoSmithKlinecollaborator
Study Sites (1)
HillTop Research Corporation
St. Petersburg, Florida, 33710, United States
Related Publications (1)
Hogan DJ, Saenz AB. Phototoxic and photoallergic potential of tazarotene foam 0.1% in 2 phase 1 patch studies. Cutis. 2012 Nov;90(5):266-71.
PMID: 23270200BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
GSK Clinical Trials
GlaxoSmithKline
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
May 5, 2010
First Posted
May 7, 2010
Study Start
June 14, 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
Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.