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

Basilea Pharmaceutica

Status and phase: Completed; Phase 3

Conditions: Hand Dermatoses

Treatments: Drug: alitretinoin

Study type: Interventional

Funder types: Industry

Identifiers

NCT00124436

BAP00091

Details and patient eligibility

About

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.

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Other

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind