- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01112787
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
Status
Completed
Conditions
Intervention / Treatment
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.
Sponsor
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
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 114571
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
-
Annotated Case Report Form
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Individual Participant Data Set
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Study Protocol
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Informed Consent Form
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
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Dataset Specification
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Statistical Analysis Plan
Information identifier: 114571Information comments: For additional information about this study please refer to the GSK Clinical Study Register
-
Clinical Study Report
Information identifier: 114571Information 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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