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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
History of Changes
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, 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:

MedlinePlus related topics: Eczema
U.S. FDA Resources

Further study details as provided by GlaxoSmithKline:

Primary Outcome Measures:
  • Response as assessed by Physicans Global Assessment (PGA) [ Time Frame: 24 weeks (end-of treatment) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00817063

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

Publications:

Responsible Party: GlaxoSmithKline ( Stiefel, a GSK Company )
ClinicalTrials.gov Identifier: NCT00817063     History of Changes
Other Study ID Numbers: 117183, BAP01346
Study First Received: January 5, 2009
Last Updated: April 18, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by GlaxoSmithKline:
retinoid treatment
fingertip dermatitis
hyperkeratotic hand eczema
vesicular hand eczema
pompholyx

Additional relevant MeSH terms:
Eczema
Dermatitis
Skin Diseases
Skin Diseases, Eczematous
Alitretinoin
Tretinoin
 Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Keratolytic Agents
Dermatologic Agents

ClinicalTrials.gov processed this record on May 16, 2013