A Study to Evaluate the Potential of Tazarotene Foam to Cause a 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 Phototoxic Potential Of Topically Applied Tazarotene Foam In Healthy Volunteers

The purpose of this study is to evaluate the potential of Tazarotene Foam to induce a phototoxic reaction when exposed to UV and VIS light on skin of healthy volunteers.

Study Overview

• Status: Completed
• Conditions: Acne Vulgaris
• Intervention / Treatment: Drug: Tazarotene Foam without irradiation; Drug: Tazarotene Foam with UVA and UVB irradiation; Drug: Tazarotene Foam with UVA, UVB, and visible light; Drug: Vehicle Foam without irradiation; Drug: Vehicle Foam with UVA and UVB irradiation; Drug: Vehicle Foam with UVA and UVB and visible light irradiation; Drug: No Treatment without irradiation; Drug: No Treatment with UVA and UVB irradiation; Drug: No Treatment with UVA and UVB and visible light irradiation

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 a phototoxic reaction in healthy adult volunteers. Approximately 40 healthy, male and female, volunteer subjects aged 18 to 65 years will be enrolled.

Each subject will be exposed to three (3) sets of three (3) patches containing Tazarotene Foam, Vehicle Foam and a Blank Patch (no study product). Each patch set will be applied to randomized sites on the subject's back. Patch sets will be removed and evaluated after 24 hours of exposure. The exposed patch sites will then be irradiated (exposed to light) and evaluated at 1 hour post irradiation and at 24, 48, and 72 hours.

• Study Type: Interventional
• Enrollment (Actual): 38
• Phase: Phase 1

Contacts and Locations

Study Locations

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

Participation Criteria

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), 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.

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 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.
• Used systemic or topical corticosteroids or other immunosuppressive medications within 4 weeks of Screening Visit 1.
• 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 Screening Visit 1.
• Used antihistamines, selective leukotriene receptor antagonists (eg, montelukast sodium, zafirlukast), or mast cell stabilizers (eg, cromolyn sodium or nedocromil sodium) within 4 weeks of Screening Visit 1.
• Used nonsteroidal anti inflammatory medications within 2 weeks of Screening Visit 1.
• 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

How is the study designed?

Design Details

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

Number of Arms

9

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Tazarotene Foam without irradiation; Subjects will be exposed to Tazarotene Foam Patch without irradiation	Drug: Tazarotene Foam without irradiation; Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Experimental: Tazarotene Foam with UVA and UVB irradiation; Subjects will be exposed to Tazarotene Foam Patch with UVA and UVB irradiation	Drug: Tazarotene Foam with UVA and UVB irradiation; Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Experimental: Tazarotene Foam with UVA , UVB, and visible light irradiation; Subjects will be exposed to Tazarotene Foam with UVA and UVB and visible light irradiation	Drug: Tazarotene Foam with UVA, UVB, and visible light; Each subject will be exposed to a patch with tazarotene foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Placebo Comparator: Vehicle Foam without irradiation; Subjects will be exposed to Vehicle Foam Patch without irradiation	Drug: Vehicle Foam without irradiation; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Placebo Comparator: Vehicle Foam with UVA and UVB irradiation; Subjects will be exposed to Vehicle Foam Patch with UVA and UVB irradiation	Drug: Vehicle Foam with UVA and UVB irradiation; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Placebo Comparator: Vehicle Foam with UVA and UVB and visible light irradiation; Subjects will be exposed to Vehicle Foam Patch with UVA and UVB and visible light irradiation	Drug: Vehicle Foam with UVA and UVB and visible light irradiation; Each subject will be exposed to a patch with vehicle foam during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Sham Comparator: No Treatment without irradiation; Subjects will be exposed to a Blank Patch without irradiation	Drug: No Treatment without irradiation; Each subject will be exposed to a blank patch during a single, 24 hour application period. This patch will then be removed and those sites will serve as nonirradiated control. Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Sham Comparator: No Treatment with UVA and UVB irradiation; Subjects will be exposed to a Blank Patch with UVA and UVB irradiation	Drug: No Treatment with UVA and UVB irradiation; Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to ultraviolet A (UVA) and to UVA/ultraviolet B (UVB) radiation wavelengths (UV only). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.
Sham Comparator: No Treatment with UVA and UVB and visible light irradiation; Subjects will be exposed to a Blank Patch with UVA and UVB and visible light irradiation	Drug: No Treatment with UVA and UVB and visible light irradiation; Each subject will be exposed to a blank patch during a single, 24 hour application period. The patch will be removed and that site will be exposed to UVA, UVA/UVB, and visible light (VIS) wavelengths (UV plus VIS). Patch sites will be evaluated for signs of inflammatory skin responses (eg, erythema and local skin reactions) and superficial effects 1 ±0.25 hour after patch removal, and during follow-up visits at 24 ±1 hours, 48 ±2 hours, and 72 ±2 hours after patch removal.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Inflammatory skin responses	Evaluation of patch sites for inflammatory skin responses and superficial effects following 24 hours of exposure and following irradiation on Day 2	Day 2-5 (24, 48, 72 hours following patch application).

Collaborators and Investigators

• Sponsor: Stiefel, a GSK Company
• Collaborators: GlaxoSmithKline

Publications and helpful links

General Publications

• 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.

Helpful Links

• Researchers can use this site to request access to anonymised patient level data and/or supporting documents from clinical studies to conduct further research.

Study record dates

Study Major Dates

• Study Start (Actual): April 1, 2010
• Primary Completion (Actual): April 10, 2010
• Study Completion (Actual): April 10, 2010

Study Registration Dates

• First Submitted: April 30, 2010
• First Submitted That Met QC Criteria: May 3, 2010
• First Posted (Estimate): May 4, 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: phototoxicity; Healthy volunteer study
• Additional Relevant MeSH Terms: Skin Diseases; Acneiform Eruptions; Sebaceous Gland Diseases; Acne Vulgaris; Physiological Effects of Drugs; Dermatologic Agents; Micronutrients; Vitamins; Keratolytic Agents; Vitamin B Complex; Nicotinic Acids; Tazarotene
• Other Study ID Numbers: 114573

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. Informed Consent Form
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
2. Study Protocol
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
3. Annotated Case Report Form
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
4. Dataset Specification
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
5. Statistical Analysis Plan
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
6. Individual Participant Data Set
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register
7. Clinical Study Report
   Information identifier: 114573
   Information comments: For additional information about this study please refer to the GSK Clinical Study Register