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

Sponsor

Basilea Pharmaceutica (Industry)

Overall Status

Completed

CT.gov ID

NCT00309621

Collaborator

(none)

250

Enrollment

Locations

Duration (Months)

7.6

Patients Per Site

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

Patients with severe chronic hand dermatitis, that has not responded to topical treatment, including topical steroids and the avoidance of aggravating factors, will be treated with the oral medication alitretinoin. The study aims to investigate the safety and efficacy of the medication when given over a period of 6 months.

Condition or Disease	Intervention/Treatment	Phase
Hand Dermatoses	Drug: alitretinoin	Phase 3

Detailed Description

For severe, chronic hand dermatitis, refractory to topical treatment and the avoidance of aggravating factors such as allergens and irritants, no registered systemic treatment is available. Current systemic treatment options consist in the off-label use of systemic immune suppressants, such as cyclosporine, methotrexate.

Severe chronic hand dermatitis is a debilitating disease, with massive impact on social life and working ability. A huge proportion of the population suffers for more than a decade, and job losses are a frequent consequence.

This open-label trial investigates the safety and efficacy of oral alitretinoin 30mg as a single daily dose for up to 6 months. The trial is complementary to the pivotal efficacy study BAP00089.

Study Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

Safety and Efficacy of Alitretinoin in the Treatment of Severe Refractory Chronic Hand Dermatitis

Study Start Date :

Apr 1, 2006

Actual Primary Completion Date :

Apr 1, 2007

Actual Study Completion Date :

May 1, 2007

Outcome Measures

Primary Outcome Measures

Safety: []
Adverse Events []
Safety Laboratory []
Radiological investigations (bone density, x-ray) []

Secondary Outcome Measures

Physicians Global Assessment []
modified Total Lesion Symptom Score []
Patients Global Assessment []
Patient Defined Outcomes []

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Chronic hand dermatitis, rated as severe by physicians global assessment, present for at least 6 months, that has not responded to the avoidance of allergens and irritants and the use of topical steroids

Exclusion Criteria:

female of childbearing potential, unless participating in a pregnancy prevention program
psoriasis
active major psychiatric condition

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1		Edmonton	Alberta	Canada	T6G2G3
2		Vancouver	British Columbia	Canada	V5O3Y1
3		Winnipeg	Manitoba	Canada	R3C1R4
4		Hawkesbury	Ontario	Canada	K6A1A1
5		London	Ontario	Canada	N6H1S9
6		Markham	Ontario	Canada	L3P1A8
7		Oakville	Ontario	Canada	L6J7W5
8		Montreal	Quebec	Canada	H3X1V6
9		Sheerbroke	Quebec	Canada	J1H1Z1
10		Quebec		Canada	G1J1X7
11		Berlin		Germany	12353
12		Berlin		Germany	13439
13		Frankfurt		Germany	60326
14		Hamburg		Germany	20246
15		Hamburg		Germany	20354
16		Hamburg		Germany	22143
17	Abt. Klinische Sozialmedizin	Heidelberg		Germany	69115
18		Ibbenbüren		Germany	49477
19		Köln		Germany	51143
20		Lübeck		Germany	23558
21		Mönchengladbach		Germany	41061
22		München		Germany	81375
23		Münster		Germany	48143
24		Osnabrück		Germany	49078
25		Potsdam		Germany	14482
26		Viersen		Germany	41747
27		Wuppertal		Germany	42275
28		Gdansk		Poland
29		Krakow		Poland	31-462
30		Lublin		Poland
31		Opole		Poland	45-372
32		Szcecin		Poland
33		Wroclaw		Poland