Last updated: 11/07/2018 07:55:03

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

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GSK study ID
114572
See study documents
Clinicaltrials.gov ID
NCT01114841
EudraCT ID
Not applicable
EU CT Number
Not applicable
Trial status
Completed
Completed
Overview
Eligibility
Locations
Study documents
Results summary
Plain language summaries
Additional information

Trial overview

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
Trial description: 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.
Primary purpose:
Basic Science
Trial design:
Parallel Assignment
Masking:
Single (Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:

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:
Not applicable
Interventions:
Drug: Tazarotene Foam
Drug: Vehicle Foam
Enrollment:
254
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Jeff Berg, Jim Bowman, Alessandra Alio. The Cumulative Irritation and Contact Sensitization Potential of Topical Tazarotene Foam, 0.1% in 2 Single-Center, Evaluator-Blinded, Randomized Vehicle-Controlled Phase 1 Patch Studies in Healthy Volunteers (W0260-101& 102). Cutis. 2012;90(4):206-211.
Medical condition
Acne Vulgaris
Product
tazarotene
Collaborators
GSK
Study date(s)
March 2010 to June 2010
Type
Interventional
Phase
1

Participation criteria

Sex
Female & Male
Age
18 - 65 years
Accepts healthy volunteers
Yes
  • 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.
  • Female who is pregnant, trying to become pregnant, or breast feeding.
  • Considered unable or unlikely to attend the necessary visits.
Inclusion and exclusion 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.

Trial location(s)

Location
Status
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Location
HillTop Research Corporation
Scottsdale, AZ, United States, 85251
Status
Study Complete
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Study documents

Clinical study report
Available language(s): English
Download document(s)
Scientific result summary
Available language(s): English
Download document(s)

If you wish to request for full study report, please contact - [email protected]

Results overview

Refer to study documents

Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2010-26-06

Plain language summaries

Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.

Additional information about the trial

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