A Study Assessing GW870086's Potential to Cause Skin Thinning

NCT01381445 | Completed Phase 1

• 1 other identifier: 113435
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

This study is a randomised, double-blind, placebo-controlled study of topical GW870086 to explore the potential for skin thinning in healthy adult volunteers after 42±2 days of treatment. Twenty (20) healthy volunteers will be randomised to receive placebo and GW870086 2% cream, they will also receive either of the following treatments: GW870086 0.2% cream, or clobetasol propionate 0.05% cream.

Conditions

Dermatitis, Atopic

Outcome Measures

Primary Outcomes (1)

• Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo

  Days; 1, 14, 21, 28, 42, 43

Secondary Outcomes (6)

• Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia

  Days; 7, 14, 21, 28, 35, 42, 43

• The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs

  6 weeks

• Plasma concentrations of GW870086

  Days 14 & 42

• Cmax of GW870086

  Days 14 & 42

• Tmax of GW870086

  Days 14 & 42

Study Arms (2)

GW870086 0.2% & GW870086 2%

EXPERIMENTAL

GW870086 0.2%, 2% \& placebo each applied to an identified area for 42 days.

Drug: GW870086 0.2%; Drug: GW870086 2%; Drug: Placebo

GW870086 2% & Clobetasol Propionate

EXPERIMENTAL

GW870086 2% \& placebo applied to an identified area for 42 days, while Clobetasol Propionate is applied to an area for 21 days

Drug: GW870086 2%; Drug: Clobetasol Propionate; Drug: Placebo

Interventions

GW870086 0.2% DRUG

White to slightly coloured opaque cream

GW870086 0.2% & GW870086 2%

GW870086 2% DRUG

White to slightly coloured opaque cream

GW870086 0.2% & GW870086 2%; GW870086 2% & Clobetasol Propionate

Clobetasol Propionate DRUG

White cream

GW870086 2% & Clobetasol Propionate

Placebo DRUG

White to slightly coloured opaque cream

GW870086 0.2% & GW870086 2%; GW870086 2% & Clobetasol Propionate

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• AST (Aspartate aminotransferase), ALT (Alanine aminotransferase), alkaline phosphatase and bilirubin ≤ 1.5xULN (Upper limit of normal)(isolated bilirubin \>1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin \<35%).
• Healthy as determined by an experienced physician.
• Male or female between 18 and 55 years of age inclusive.
• A female subject is eligible to participate if she is of:
• Non-childbearing potential defined as pre-menopausal females with a documented tubal ligation or hysterectomy; or postmenopausal. Females on hormone replacement therapy (HRT) and whose menopausal status is in doubt will be required to use one of the protocol contraception methods if they wish to continue their HRT during the study.
• Male subjects with female partners of child-bearing potential must agree to use one of the protocol contraception methods.
• BMI within the range 19.0 - 29.0 kg/m2 (inclusive).
• Capable of giving written informed consent.
• Single QTc, QTcB \< 450 msec; or QTc \< 480 msec in subjects with Bundle Branch Block.

You may not qualify if:

• Any sign of weak or fragile skin, striae, or similar, in the areas which will be evaluated.
• Tattoos or body art on the upper arms.
• Foreseeable intensive UV exposure during the study (solar or artificial). Subjects must not be exposed to direct sunlight or skin tanning devices (e.g. sunbed) for the duration of the study.
• A positive pre-study test for Hepatitis B or Hepatitis C antibody within 3 months of screening.
• Current or chronic history of liver disease, or known hepatic or biliary abnormalities.
• A positive pre-study drug/alcohol screen.
• A positive test for HIV (Human Immunodeficiency Virus) antibody.
• History of regular alcohol consumption within 6 months of the study.
• The subject has participated in a clinical trial and has received an investigational product within the following time period prior to the first dosing day in the current study: 30 days, 5 half-lives or twice the duration of the biological effect of the investigational product (whichever is longer).
• Exposure to more than four new chemical entities within 12 months prior to the first dosing day.
• Use of prescription or non-prescription drugs, including vitamins, herbal and dietary supplements within 7 days (or 14 days if the drug is a potential enzyme inducer) or 5 half-lives (whichever is longer) prior to the first dose of study medication, unless in the opinion of the Investigator and GSK Medical Monitor the medication will not interfere with the study procedures or compromise subject safety.
• History of sensitivity to any of the study medications or components thereof.
• Where participation in the study would result in donation of blood or blood products in excess of 500 mL within a 56 day period.
• Unwillingness or inability to follow the procedures outlined in the protocol.
• Subject is mentally or legally incapacitated.

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Berlin, 10117, Germany

Location

Related 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.
• Results for study 113435 can be found on the GSK Clinical Study Register.

MeSH Terms

Conditions

Dermatitis, Atopic

Interventions

Clobetasol

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases

Intervention Hierarchy (Ancestors)

Betamethasone; Steroids, Fluorinated; Steroids; Fused-Ring Compounds; Polycyclic Compounds

Study Officials

• GSK Clinical Trials

  GlaxoSmithKline

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: OTHER
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 16, 2011
• First Posted: June 27, 2011
• Study Start: April 14, 2011
• Primary Completion: July 7, 2011
• Study Completion: July 7, 2011
• Last Updated: July 21, 2017

Record last verified: 2017-07

Data Sharing

• IPD Sharing: Will share

Locations

DE (1)