Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema (HANDEL)

This study has been completed.
Sponsor:
Collaborator:
Basilea Pharmaceutica
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier:
NCT00817063
First received: January 5, 2009
Last updated: April 18, 2013
Last verified: March 2013

January 5, 2009
April 18, 2013
January 2009
April 2012   (final data collection date for primary outcome measure)
Response as assessed by Physicans Global Assessment (PGA) [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00817063 on ClinicalTrials.gov Archive Site
  • Patients Global Assessment (PaGA) [ Time Frame: 24 weeks (end-of-treatment) ] [ Designated as safety issue: No ]
  • Modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]
  • Extent of disease [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]
  • Adverse events, laboratory tests [ Time Frame: continuosly during treatment ] [ Designated as safety issue: Yes ]
  • Psychiatric questionaires (BSI-53, GHQ-9) [ Time Frame: continously during treatment ] [ Designated as safety issue: Yes ]
  • Bone densitometry and bone x-rays [ Time Frame: 24 weeks (end-of treatment), follow-up 48 weeks post treatment ] [ Designated as safety issue: Yes ]
  • Ophthalmologic evaluation [ Time Frame: 24 weeks (end of treatment) ] [ Designated as safety issue: Yes ]
  • Audiologic evaluation [ Time Frame: 24 weeks (end-of-treatment) ] [ Designated as safety issue: Yes ]
Same as current
Not Provided
Not Provided
 
Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema
Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

The purpose of this study is to investigate the safety and efficacy of alitretinoin in the treatment of severe chronic hand eczema that does not respond to treatment with potent topical steroids.

Chronic hand eczema (CHE)is a distressing disease that poses difficult problems for dermatologists. CHE leads to considerable work-absenteeism, disability and exclusion from labour market. Conventional treatments, including highly potent topical steroids, yield often unsatisfactory results. This study investigates the efficacy and safety of oral alitretinoin, a retinoid, in patients who have not responded to avoidance of causative factors, such as contact allergens and skin irritants, non-medicated skin care and highly potent topical steroids. Eligible patients are randomly assigned to receive alitretinoin or a placebo.

Interventional
Phase 3
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Eczema
  • Drug: alitretinoin
    Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
  • Drug: Placebo
    Patients receive matching placebo for up to 24 weeks
  • Experimental: Alitretinoin
    Patients will receive alitretinoin 30mg capsule for up to 24 weeks
    Intervention: Drug: alitretinoin
  • Experimental: Placebo
    Patients will receive placebo 30mg capsule for up to 24 weeks
    Intervention: Drug: Placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
600
August 2012
April 2012   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • all types of chronic hand eczema, lasting for at least 6 months since initial diagnosis
  • rated as severe by the physician
  • unresponsive to highly potent topical corticosteroids, such as clobetasol

Exclusion Criteria:

  • patients whose disease is adequately controlled by standard non-medicated therapy, including potent topical steroids, skin moisturizers, and avoidance of allergens and irritants
  • patients with known allergens and irritants, who have not made a reasonable effort to avoid the substances
  • patients with psoriasis lesions
  • active fungal, bacterial or viral infections of the hands
  • female patients who are pregnant or breastfeeding
  • female patients of childbearing potential who cannot use or will not commit to use two effective methods of contraception
Both
18 Years to 75 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00817063
117183, BAP01346
No
GlaxoSmithKline ( Stiefel, a GSK Company )
Stiefel, a GSK Company
Basilea Pharmaceutica
Study Director: GSK Clinical Trials GlaxoSmithKline
GlaxoSmithKline
March 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP