Advertisement

Topics

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

2014-08-27 03:14:00 | BioPortfolio

Summary

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.

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 Design

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Basic Science

Conditions

Healthy

Intervention

Tazarotene Foam without irradiation, Tazarotene Foam with UVA and UVB irradiation, Tazarotene Foam with UVA, UVB, and visible light, Vehicle Foam without irradiation, Vehicle Foam with UVA and UVB irradiation, Vehicle Foam with UVA and UVB and visible lig

Location

HillTop Research Corporation
Scottsdale
Arizona
United States
85251

Status

Active, not recruiting

Source

Stiefel, a GSK Company

Results (where available)

View Results

Links

Published on BioPortfolio: 2014-08-27T03:14:00-0400

Clinical Trials [698 Associated Clinical Trials listed on BioPortfolio]

A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

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

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.

A Study to Evaluate the Safety and Efficacy of Tazarotene Foam, 0.1%, in Subjects With Common Facial Acne

The purpose of this study is to assess safety and efficacy of a new foam formulation of tazarotene in subjects with acne vulgaris.

A Study to Evaluate the Bioavailability of Tazarotene Foam, 0.1%, and Tazorac Gel, 0.1%, in Subjects With Acne Vulgaris

The purpose of this study is to assess systemic exposure of a new foam formulation of tazarotene, 0.1% compared with Tazorac Gel, 0.1%. The study design and dosing regimen are based on pr...

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.

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.

PubMed Articles [1381 Associated PubMed Articles listed on BioPortfolio]

Safety and Efficacy of a Halobetasol/Tazarotene Fixed Combination in the Treatment of Moderate-to-Severe Plaque Psoriasis: Results of two Phase 3 randomized controlled trials.

Topical corticosteroids are the mainstay of psoriasis treatment; long-term safety concerns limit use. Combination with tazarotene may optimize efficacy, minimizing safety/tolerability concerns, In pat...

Flexible and Lightweight Pressure Sensor Based on Carbon Nanotube/Thermoplastic Polyurethane Aligned Conductive Foam with Superior Compressibility and Stability.

Flexible and lightweight carbon nanotubes (CNTs)/thermoplastic polyurethane (TPU) conductive foam with a novel aligned porous structure was fabricated. The density of the aligned porous material was a...

Destabilization, Propagation, and Generation of Surfactant-Stabilized Foam during Crude Oil Displacement in Heterogeneous Model Porous Media.

Foam flooding in porous media is of increasing interest due to its numerous applications such as enhanced oil recovery, aquifer remediation, and hydraulic fracturing. However, the mechanisms of oil-fo...

Transforming fish scale waste into an efficient filler for starch foam.

In this work modified fish scale waste (FS) was used as a filler in order to improve the properties of starch foam prepared by a baking process. The FS was modified under two calcination conditions: a...

Highly porous copper ferrite foam: A promising adsorbent for efficient removal of As(III) and As(V) from water.

A novel copper ferrite foam fabricated on Fe-Ni foam substrate was synthesized via a simple hydrothermal method to efficiently remove arsenic from aqueous solution. Scanning electron microscopy (SEM),...

Medical and Biotech [MESH] Definitions

Irradiation of one half or both halves of the body in the treatment of disseminated cancer or widespread metastases. It is used to treat diffuse metastases in one session as opposed to multiple fields over an extended period. The more frequent treatment modalities are upper hemibody irradiation (UHBI) or lower hemibody irradiation (LHBI). Less common is mid-body irradiation (MBI). In the treatment of both halves of the body sequentially, hemibody irradiation permits radiotherapy of the whole body with larger doses of radiation than could be accomplished with WHOLE-BODY IRRADIATION. It is sometimes called "systemic" hemibody irradiation with reference to its use in widespread cancer or metastases. (P. Rubin et al. Cancer, Vol 55, p2210, 1985)

A dry artificial sterile sponge of fibrin prepared by clotting with thrombin a foam or solution of fibrinogen. It is used in conjunction with thrombin as a hemostatic in surgery at sites where bleeding cannot be controlled by more common methods. (From Martindale, The Extra Pharmacopoeia, 30th ed, p648)

External or interstitial irradiation to treat lymphomas (e.g., Hodgkin's and non-Hodgkin's lymphomas) and lymph node metastases and also some autoimmune diseases, such as rheumatoid arthritis.

Irradiation of the whole body with ionizing or non-ionizing radiation. It is applicable to humans or animals but not to microorganisms.

A suspension of radioactive gold particles emitting negative beta particles and gamma irradiation. It was formerly used for liver scans and irradiation treatment of some metastatic malignancies.

More From BioPortfolio on "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"

Advertisement
Quick Search
Advertisement
Advertisement

 

Relevant Topics

Dermatology
Acne Dermatology Eczema Psoriasis Wound Care Dermatology is the medical specialty concerned with the diagnosis and treatment of skin disorders (Oxford Medical Dictionary). As well as studying how the skin works, dermatology covers...

Nutrition
Within medicine, nutrition (the study of food and the effect of its components on the body) has many different roles. Appropriate nutrition can help prevent certain diseases, or treat others. In critically ill patients, artificial feeding by tubes need t...


Searches Linking to this Trial