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

This study has been completed.
ClinicalTrials.gov Identifier:
First Posted: January 6, 2009
Last Update Posted: October 12, 2017
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.
Basilea Pharmaceutica
Information provided by (Responsible Party):
GlaxoSmithKline ( Stiefel, a GSK Company )
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.

Condition Intervention Phase
Eczema Drug: alitretinoin Drug: Placebo Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

Resource links provided by NLM:

Further study details as provided by GlaxoSmithKline ( Stiefel, a GSK Company ):

Primary Outcome Measures:
  • Response as assessed by Physicans Global Assessment (PGA) [ Time Frame: 24 weeks (end-of treatment) ]

Secondary Outcome Measures:
  • Patients Global Assessment (PaGA) [ Time Frame: 24 weeks (end-of-treatment) ]
  • Modified Total Lesion Symptom Score (mTLSS) [ Time Frame: 24 weeks (end-of treatment) ]
  • Extent of disease [ Time Frame: 24 weeks (end-of treatment) ]
  • Adverse events, laboratory tests [ Time Frame: continuosly during treatment ]
  • Psychiatric questionaires (BSI-53, GHQ-9) [ Time Frame: continously during treatment ]
  • Bone densitometry and bone x-rays [ Time Frame: 24 weeks (end-of treatment), follow-up 48 weeks post treatment ]
  • Ophthalmologic evaluation [ Time Frame: 24 weeks (end of treatment) ]
  • Audiologic evaluation [ Time Frame: 24 weeks (end-of-treatment) ]

Enrollment: 600
Study Start Date: January 2009
Study Completion Date: August 2012
Primary Completion Date: April 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Alitretinoin
Patients will receive alitretinoin 30mg capsule for up to 24 weeks
Drug: alitretinoin
Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
Experimental: Placebo
Patients will receive placebo 30mg capsule for up to 24 weeks
Drug: Placebo
Patients receive matching placebo for up to 24 weeks

Detailed Description:
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.

Information from the National Library of Medicine

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

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
  Contacts and Locations
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 ClinicalTrials.gov identifier (NCT number): NCT00817063

  Show 70 Study Locations
Sponsors and Collaborators
Stiefel, a GSK Company
Basilea Pharmaceutica
Study Director: GSK Clinical Trials GlaxoSmithKline
  More Information

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Stiefel, a GSK Company
ClinicalTrials.gov Identifier: NCT00817063     History of Changes
Other Study ID Numbers: 117183
BAP01346 ( Other Identifier: Basilea Pharmaceutica )
First Submitted: January 5, 2009
First Posted: January 6, 2009
Last Update Posted: October 12, 2017
Last Verified: March 2013

Keywords provided by GlaxoSmithKline ( Stiefel, a GSK Company ):
retinoid treatment
fingertip dermatitis
hyperkeratotic hand eczema
vesicular hand eczema

Additional relevant MeSH terms:
Skin Diseases
Skin Diseases, Eczematous
Antineoplastic Agents
Keratolytic Agents
Dermatologic Agents