Version 2.0 Oral Alitretinoin Treatment in Patients with PPP
Research type
Research Study
Full title
Efficacy of oral alitretinoin treatment in patients with palmo-plantar pustulosis (PPP) inadequately responding to standard topical treatment.
IRAS ID
66701
Contact name
Catherine Smith
Sponsor organisation
GlaxoSmithKline R&D Ltd
Eudract number
2010-022843-39
Clinicaltrials.gov Identifier
Research summary
Palmo-plantar pustulosis (PPP) is an inflammatory skin disease, affecting palms and soles, characterised by sterile pustules and red scaly skin. It??s a debilitating disease which interferes with daily activities and with the ability to work. PPP is difficult to treat as topical drugs have shown limited efficacy. A case report has show success in treating PPP with alitretinoin, which is already used to treat chronic hand eczma. The aim of this pilot study is to determine the response that alitretinoin treatment has on patients suffering from the condition palmo-plantar pustulosis (PPP) who have inadequately responded to standard topical treatment. The response alitretinoin treatment has on PPP will be determined using the palmo-plantar pustulosis psoriasis area and severity index (PPPASI) at the end of treatment (week 24), or at the latest assessment for patients who withdraw prematurely. The secondary objectives of the study are: - to assess the response of pustule lesions to total pustule count - to assess the response of psorasis lesions in locations, other than the hands, to the treatment - to assess the response of nail involvement to the treatment - to collect safety data for alitretinoin The study will be performed in 5 centres across Europe including one site in the U.K. 30 patients are to be recruited and the patients will be randomized to receive either 30mg alitretinoin or placebo in a 2:1 fashion. Clinical evaluations will be performed every 4 weeks and a safety follow-up visit is planned 5 weeks after the end of treatment. If the symptoms have not improved after 12 weeks of treatment the investigator should consider to withdraw the patient from the study.
REC name
London - Central Research Ethics Committee
REC reference
11/LO/0137
Date of REC Opinion
2 Mar 2011
REC opinion
Favourable Opinion