Follow-up Efficacy and Safety of Alitretinoin in Severe Chronic Hand Dermatitis

Basilea Pharmaceutica300 enrolled

Overview

Patients who have been treated in study protocol BAP089 may have responded to treatment, and subsequently relapsed to \>75% of the baseline disease severity, will be investigated for response to further treatment with alitretinoin. Also, patients who have responded with mild or moderate disease will be investigated for additional treatment effect after prolongated treatment.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

OTHER

Masking

DOUBLE

Enrollment

300

Conditions

Hand Dermatoses

Interventions

alitretinoinDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Previous participation in protocol BAP089 * Response of severe, treatment refractory hand dermatitis with mild or moderate, or responding patients who relapsed to 75% of baseline disease Exclusion Criteria: * Female patients who are pregnant or who want to become pregnant * Female patients of child bearing potential who cannot use or who will not commit to using two effective methods of contraception

Locations (1)

Thomas Ruzicka

Düsseldorf, Germany

Outcomes

Primary Outcomes

Response of chronic hand dermatitis to study treatment as assessed by Physicians Global Assessment, at week 12 or 24

Secondary Outcomes

Patient's global assessment

Extent of disease

Time to respond

Modified total lesion symptom score

at week 12 or 24

Data from ClinicalTrials.gov

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