Efficacy and Safety of a Retinoid in the Treatment of Severe Chronic Hand Eczema - Full Text View

Sponsored by:	Basilea Pharmaceutica
Information provided by:	Basilea Pharmaceutica
ClinicalTrials.gov Identifier:	NCT00817063

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
Chronic Hand Eczema Chronic Hand Dermatitis	Drug: alitretinoin Drug: Placebo	Phase III

Study Type:	Interventional
Study Design:	Treatment, Randomized, Double Blind (Subject, Investigator), Placebo Control, Parallel Assignment, Safety/Efficacy Study
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

Drug Information available for: 9-cis-Retinoic acid

U.S. FDA Resources

Further study details as provided by Basilea Pharmaceutica:

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 ]

Estimated Enrollment:	600
Study Start Date:	December 2008
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Alitretinoin: Experimental	Drug: alitretinoin Patients receive alitretinoin 30mg one capsule daily for up to 24 weeks
Placebo: Experimental	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

Contacts

Contact: Jürgen Maares, MD

+41 616061 ext 229

juergen.maares@basilea.com

Show 70 Study Locations

Sponsors and Collaborators

Basilea Pharmaceutica

More Information

Publications:

Ruzicka T, Lynde CW, Jemec GB, Diepgen T, Berth-Jones J, Coenraads PJ, Kaszuba A, Bissonnette R, Varjonen E, Holló P, Cambazard F, Lahfa M, Elsner P, Nyberg F, Svensson A, Brown TC, Harsch M, Maares J. Efficacy and safety of oral alitretinoin (9-cis retinoic acid) in patients with severe chronic hand eczema refractory to topical corticosteroids: results of a randomized, double-blind, placebo-controlled, multicentre trial. Br J Dermatol. 2008 Apr;158(4):808-17. Epub 2008 Feb 21.

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.

Diepgen TL, Agner T, Aberer W, Berth-Jones J, Cambazard F, Elsner P, McFadden J, Coenraads PJ. Management of chronic hand eczema. Contact Dermatitis. 2007 Oct;57(4):203-10. Review.

Responsible Party:	Basilea Pharmaceutica Ltd. ( Jürgen Maares, Project Physician )
Study ID Numbers:	BAP01346
Study First Received:	January 5, 2009
Last Updated:	August 21, 2009
ClinicalTrials.gov Identifier:	NCT00817063 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Basilea Pharmaceutica:

retinoid treatment
hyperkeratotic hand eczema
pompholyx
vesicular hand eczema
fingertip dermatitis

Study placed in the following topic categories:

Alitretinoin
Skin Diseases
Skin Abnormalities
Skin Diseases, Eczematous
Eczema, Dyshidrotic

Acrodermatitis
Eczema
Congenital Abnormalities
Dermatitis

Additional relevant MeSH terms:

Alitretinoin
Skin Diseases
Antineoplastic Agents
Therapeutic Uses
Skin Abnormalities
Skin Diseases, Eczematous

Acrodermatitis
Eczema
Congenital Abnormalities
Pharmacologic Actions
Dermatitis

ClinicalTrials.gov processed this record on September 02, 2009