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

June 19, 2017 updated by: Stiefel, a GSK Company

A Phase 1, Evaluator-Blinded, Randomized, Vehicle Controlled, Study To Evaluate The Cumulative Irritation Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers

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.

Study Overview

Detailed Description

This is a Phase 1, single center, evaluator-blinded, randomized, vehicle controlled study to evaluate the potential of tazarotene foam to induce cutaneous irritation using a 21 day cumulative irritation assay in healthy adult volunteers. Approximately 40 healthy male and female volunteer subjects aged 18 to 65 years will be enrolled. All subjects will be exposed to patches containing tazarotene foam, vehicle foam, sodium lauryl sulfate 0.5% (positive control), and distilled water (negative control). Each set of patches will be applied to the same randomized sites once daily for 21 days; patches will be removed after 24 ±1 hours and the patch sites will be evaluated for signs inflammatory skin responses (eg, erythema, edema, papules) and superficial effects.

Study Type

Interventional

Enrollment (Actual)

39

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Arizona
      • Scottsdale, Arizona, United States, 85251
        • HillTop Research Corporation

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years to 63 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 .
  • 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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Tazarotene Foam
Subjects will be exposed to patches containing Tazarotene Foam 0.1%,
Tazarotene Foam
Placebo Comparator: Vehicle Foam
Subjects will be exposed to patches containing Vehicle Foam.
Vehicle Foam
Active Comparator: Sodium Laural Sulfate
Subjects will be exposed to patches containing Sodium Laural Sulfate.
Sodium Laural Sulfate
Placebo Comparator: Distilled Water
Subjects will be exposed to patches containing Distilled Water.
Distilled Water

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Inflammatory skin responses
Time Frame: 21 days
Patch sites will be evaluated for signs of inflammatory skin responses (e.g. erythema, edema, papules) and superficial effects.
21 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Collaborators

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

March 26, 2010

Primary Completion (Actual)

April 26, 2010

Study Completion (Actual)

April 26, 2010

Study Registration Dates

First Submitted

April 27, 2010

First Submitted That Met QC Criteria

April 27, 2010

First Posted (Estimate)

April 28, 2010

Study Record Updates

Last Update Posted (Actual)

June 20, 2017

Last Update Submitted That Met QC Criteria

June 19, 2017

Last Verified

June 1, 2017

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

Patient-level data for this study will be made available through www.clinicalstudydatarequest.com following the timelines and process described on this site.

Study Data/Documents

  1. Annotated Case Report Form
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  2. Individual Participant Data Set
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  3. Study Protocol
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  4. Informed Consent Form
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  5. Dataset Specification
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  6. Statistical Analysis Plan
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register
  7. Clinical Study Report
    Information identifier: 114571
    Information comments: For additional information about this study please refer to the GSK Clinical Study Register

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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