Last updated: 11/07/2018 06:06:50
A study assessing GW870086's potential to cause skin thinning
Clinicaltrials.gov ID
EudraCT ID
EU CT Number
Not applicable
Trial status
Completed
Completed
Trial overview
Official title: A randomised, double-blind (for GW870086), placebo-controlled study of topical GW870086 formulation to explore the potential for skin thinning in healthy adult volunteers
Trial description: 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.
Primary purpose:
Other
Trial design:
Crossover Assignment
Masking:
Double (Participant, Investigator)
Allocation:
Randomized
Primary outcomes:
Change from baseline in skin thickness using ultrasound between GW870086 (0.2% and 2%) versus placebo
Timeframe: Days; 1, 14, 21, 28, 42, 43
Secondary outcomes:
Clinical evaluation of treated skin areas using assessment of clinical signs and symptoms according to the visual scores of skin atrophy and telangiectasia
Timeframe: Days; 7, 14, 21, 28, 35, 42, 43
The assessment of safety parameters; adverse events, clinical laboratory tests, ECG, and vital signs
Timeframe: 6 weeks
Plasma concentrations of GW870086
Timeframe: Days 14 & 42
Cmax of GW870086
Timeframe: Days 14 & 42
Tmax of GW870086
Timeframe: Days 14 & 42
AUC of GW870086
Timeframe: Days 14 & 42
Interventions:
Drug: GW870086 0.2%
Drug: GW870086 2%
Drug: Clobetasol Propionate
Drug: Placebo
Enrollment:
20
Observational study model:
Not applicable
Primary completion date:
Not applicable
Time perspective:
Not applicable
Clinical publications:
Dölle S,Hielscher N, Bareille P.J, Hardes K,Robertson J, Worm M.Clinical efficacy and tolerability of a novel selective corticosteroid in atopic dermatitis - two randomised controlled trials .Skin Pharmacology and Physiology.2015;28(3):159-166
Medical condition
Dermatitis, Atopic
Product
GW870086, clobetasol
Collaborators
Not applicable
Study date(s)
April 2011 to July 2011
Type
Interventional
Phase
1
Participation criteria
Sex
Female & Male
Age
18 - 55 years
Accepts healthy volunteers
Yes
- 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.
- 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.
Inclusion and exclusion criteria
Inclusion criteria:
- 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.
- 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.
A female subject is eligible to participate if she is of:
Exclusion criteria:
- 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.
- Subjects who are kept due to regulatory or juridical order in an institution.
- History of sensitivity to heparin or heparin-induced thrombocytopenia.
- Consumption of red wine, Seville oranges, grapefruit or grapefruit juice and/or pummelos, exotic citrus fruits, grapefruit hybrids or fruit juices from 7 days prior to the first dose of study medication.
Trial location(s)
Study documents
Clinical study report
Available language(s): English
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Refer to study documents
Recruitment status
Completed
Actual primary completion date
Not applicable
Actual study completion date
2011-07-07
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
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