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CompletedNCT00124475Updated May 10, 2023

Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis

A Phase 3 interventional study of alitretinoin in Hand Dermatoses, sponsored by Basilea Pharmaceutica. Completed at 1 site in Germany. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2023-05-10.

Sponsored by Basilea Pharmaceutica · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
1,035
Allocation
Randomized
Ages
18 Years to 75 Years
Sex
All
01

Study summary

The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.

Read the detailed description

Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.

Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.

02

Conditions studied

  • Hand Dermatoses

Keywords

  • Chronic Hand Dermatitis
03

In context

Lead sponsor

Basilea Pharmaceutica is the lead sponsor of 59 studies on the registry; 6 are open to participants now.

Of its 22 completed or terminated interventional studies of FDA-regulated products, 15 (68%) have results posted.

Browse Basilea Pharmaceutica studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
  • Lasting for 6 months since initial diagnosis
  • Rated severe
  • Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
  • Refractory to topical steroids

Exclusion criteria

Exclusion Criteria:

  • Female patients who are pregnant or want to become pregnant
  • Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
  • Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double
Enrollment
1,035 participants

Interventions

06

What researchers measure

Primary outcomes

  1. Physicians global assessment

  2. at week 12 or 24

Secondary outcomes

  1. Response rate per treatment group

  2. Modified total lesion symptom score

  3. Patients global assessment

  4. at week 12 or 24

  5. Time to relapse

07

Study locations

1 site
  • Thomas Ruzicka, MD
    Düsseldorf, 40225, Germany
08

References and documents

Publications

  • Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453. PubMed 15611422 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 10, 2023, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT00124475
Lead sponsor
Basilea Pharmaceutica
First posted
Jul 28, 2005
Start date
Dec 2004
Primary completion
Oct 2006
Completion
Sep 2007
Last update
May 10, 2023

Study contacts

Thomas Ruzicka, MD
principal investigator · University of Düsseldorf, Dermatological Hospital, Germany
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in May 2023. You cannot join it, but the record below documents what was studied.

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