Home » Clinical Trials » Therapeutic Areas
Therapeutic Areas: Dermatology/Plastic Surgery
Disease Category: Eczema (Atopic Dermatitis)

Trial Information

Efficacy and Safety of Alitretinoin in the Treatment of Severe Chronic Hand Eczema Refractory to Topical Therapy

Randomized, double-blind, placebo-controlled study with up to 24 weeks of treatment, with a 4-week post-treatment safety follow-up period and further follow-up period of 48 weeks after end of treatment for assessment of DXA, skeletal radiograms, bone markers, and relapse.

Patient Inclusion Criteria:

• Male patients, or female patients if post-menopausal, or hysterectomized, or if surgically castrated by bilateral oophorectomy, or if pre-menopausal and willing to use two methods of contraception under medical supervision, unless strictly abstinent
• Aged 18 to 75 years
• Chronic hand eczema
  • lasting for at least 6 months since initial diagnosis
  • rated severe according to the Physician Global Assessment (PGA)
  • refractory to previous therapy with topical corticosteroids, with a history of unsatisfactory outcome after at least 8 weeks of treatment within the previous 6 months

Patient Exclusion Criteria:

• Female patients who are pregnant or who plan to become pregnant or who are breast feeding.
• Female patients of childbearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously under medical supervision, unless strictly abstinent.
• Patients whose disease is adequately controlled by standard non-medicated therapy and standard topical corticosteroid therapy, but whose disease has relapsed following discontinuation of these treatments.
• Patients with known hypersensitivity to other retinoids or vitamin A derivatives, or to any study medication component, especially soybean oil and partly hydrogenated soybean oil.
• Patients treated with systemic corticosteroids, retinoids, or immunosuppressants, within four weeks before start of treatment (use of inhaled steroids is permitted).
• Patients treated with phototherapy UVB, PUVA, Grenz rays, or x-rays within four weeks before start of treatment.
• Patients presenting with a) psoriasis lesions, b) atopic dermatitis lesions requiring medicated treatment, c) acute episodes of pompholyx/dyshydrosis or of contact dermatitits, d) active bacterial fungal or viral infection of the hands.
• Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety or evaluation of the study, including chronic heart failure, recent myocardial infarction, chronic renal failure, chronic liver failure, unstable hypothyroidism, chronic biliary disease, uncontrolled diabetes mellitus.
• Patients with an active major psychiatric disorder.
• Patients included in the study of an investigational drug within 2 months before start of trial treatment.

Janice Orem, CMA, Research Coordinator
Dermatology Clinical Research Center of San Antonio
7810 Louis Pasteur, Suite 200
San Antonio, TX 78229
Phone: 210-692-1382
Fax: 210-614-9350
EMail: researchstaff2@dermlaser.com

View Google Map

DISCLAIMER: This site is run by CenterWatch, a publishing company that focuses on the clinical trials industry. The information provided in this service is designed to help patients find clinical trials that may be of interest to them, and to help patients contact the centers conducting the research. CenterWatch is neither promoting this research nor involved in conducting any of these trials.