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Completed

NCT Number: NCT00124436

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

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.

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Key information

Conditions

Hand Dermatoses Skin Diseases Skin and Connective Tissue Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Thomas Ruzicka

Düsseldorf, 40225, Germany

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Alitretinoin

Drug

Primary outcomes

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

Secondary outcomes

  1. Patient's global assessment

  2. Extent of disease

  3. Time to respond

  4. Modified total lesion symptom score

  5. at week 12 or 24

Sponsors and collaborators

Lead sponsor

Basilea Pharmaceutica

Industry

Registry information

Official study title

Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment

Important dates

Study start
2005
Primary completion
2007
Study completion
2007
First posted
Jul 28, 2005
Registry last updated
May 10, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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