Study 203121: A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK2894512 Cream for the Treatment of Atopic Dermatitis

  • STATUS
    Recruiting
  • sponsor
    GlaxoSmithKline
Updated on 23 November 2020

Summary

Study 203121: A Randomized, Blinded, Vehicle-Controlled, Dose-Finding Study of GSK2894512 Cream for the Treatment of Atopic Dermatitis

Description

This research study will evaluate the effectiveness and safety of two concentrations (0.5 percent [%] and 1%) and two application frequencies (once a day and twice a day) of GSK2894512 cream for the topical treatment in adolescent and adult subjects with atopic dermatitis (eczema). Results from this study will be considered when selecting the most appropriate concentration of GSK2894512 cream and application frequency in future clinical studies.

Two concentrations of GSK2894512 cream (0.5% and 1%) and a vehicle control cream will be equally randomized and evaluated following application to all atopic dermatitis lesions (except on the scalp) once daily (evening) or twice daily (morning and evening) for 12 weeks. This study will consist of 3 periods: up to 4 weeks screening, 12 weeks double-blind treatment, and 4 weeks post-treatment follow-up. The total duration of subject participation will be approximately 16 to 20 weeks. The study drug will be assigned and used for 12 weeks with a total of up to 9 visits.

In office visits will be conducted as follows: Screening Visit, Baseline Visit, Week 1, Week 2, Week 4, Week 8, Week 12, Week 14 and Week 16. The study drug will be assigned at baseline and returned at week 12.

Study related procedures include physical examinations, Atopic Dermatitis assessments by both the participant and study doctor, urine pregnancy tests for women of child bearing potential, blood draws, electrocardiograms (EKG's), optional photography and electronic diary entries.

There will be 6 groups, including 2 placebo groups and each group will be provided a different dose of study drug with instructions on how to apply on the affected areas. Each participant will be placed at random into one of the following groups:

  • GSK2894512 1% cream; apply once daily
  • GSK2894512 1% cream; apply twice daily
  • GSK2894512 0.5% cream; apply once daily
  • GSK2894512 0.5% cream; apply twice daily
  • Placebo cream; apply once daily
  • Placebo cream; apply twice daily

Details
Condition Eczema (Atopic Dermatitis - Pediatric), Eczema (Atopic Dermatitis)
Clinical Study IdentifierTX143627
SponsorGlaxoSmithKline
Last Modified on23 November 2020

Eligibility

Yes No Not Sure

Inclusion Criteria

Men and women between the ages of 12-65
Diagnosed with atopic dermatitis (Eczema)
Have an active inflammation
Willing and able to come in for all study visits
Other criteria assessed by the study doctor at the time of screening

Exclusion Criteria

Unstable course of eczema (spontaneously improving or worsening)
Significant abnormal laboratory results or chronic illnesses
Other criteria assessed by the study doctor during the screening process
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How to participate?

Step 1 Connect with a study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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