A Double-Blind, Randomised, Single Centre, Placebo-Controlled Phase II Study to Evaluate the Safety and Efficacy of a Single Subcutaneous Implant of EPT 1647 in Patients Suffering from Recurrent Polymorphous Light Eruptio

Phase 2

Recruiting

• Conditions: Polymorphous Light Eruption (PMLE); Skin - Dermatological conditions

• Registration Number: ACTRN12605000369628
• Lead Sponsor: Epitan Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2005-09-13
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

History of PMLE.

Exclusion Criteria

History of skin cancer.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To determine whether EPT 1647 implants given as a prophylactic can prevent or reduce the occurrence of symptoms like urticaria, vesiculation, papules, eczema, erithema, itching and burning associated with PMLE[Reviewed at each monthly visit]

Secondary Outcome Measures

Name	Time	Method
To establish the safety and tolerability as judged from observed Adverse Events, of a sustained release implant of EPT 1647 delivering approximately 20 mg over a 10 day period in Caucasian participants with a history of recurrent Polymorphous Light Eruption (PMLE).[Over 6 months]