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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00124436
Recruitment Status : Completed
First Posted : July 28, 2005
Last Update Posted : July 19, 2010
Information provided by:
Basilea Pharmaceutica

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Hand Dermatoses Drug: alitretinoin Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 300 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double
Official Title: Follow up Efficacy and Safety Study of BAL4979 in the Treatment of Chronic Hand Dermatitis Refractory to Topical Treatment
Study Start Date : March 2005
Primary Completion Date : January 2007
Study Completion Date : February 2007

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00124436

Thomas Ruzicka
Düsseldorf, Germany, 40225
Sponsors and Collaborators
Basilea Pharmaceutica
Principal Investigator: Thomas Ruzicka, MD University of Düsseldorf, Dermatological Hospital, Germany

Publications: Identifier: NCT00124436     History of Changes
Other Study ID Numbers: BAP00091
First Posted: July 28, 2005    Key Record Dates
Last Update Posted: July 19, 2010
Last Verified: July 2010

Keywords provided by Basilea Pharmaceutica:
Patients who have been enrolled in study protocol BAP089, and whose severe chronic hand dermatitis responded with mild or moderate disease, or who relapsed

Additional relevant MeSH terms:
Skin Diseases
Hand Dermatoses
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents