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

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 250

Inclusion Criteria

- Male patients, or female patients if post-menopausal, or hysterectomized, or if pre-menopausal and willing to use two methods of contraception under supervision of the investigator or a gynecologist.
- Aged 18 to 75 years
- Chronic hand dermatitis; all types of chronic hand dermatitis including hyperkeratotic, vesicular (e.g. pompholyx), and fingertip dermatitis, and fulfilling the following criteria:
~lasting for at least 6 months since initial diagnosis
~rated severe, according to the Physician Global Assessment (PGA)
~refractory to standard non-medicated therapy, including skin moisturization and protection, and avoidance of relevant irritants and allergens
~refractory to topical corticosteroid therapy, with unsatisfactory outcome (no response, transient response to ongoing therapy, or lack of tolerability) after at least 8 weeks of treatment within previous 12 months, unless contraindicated or not tolerated
- Written informed consent provided
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

- Patients unable to comply with the requirements of the study
- 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 supervision of the investigator or a gynecologist
- Patients whose disease is adequately controlled by standard non-medicated therapy (skin moisturization and protection, avoidance of irritants and allergens) and standard topical corticosteroid therapy
- 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 therapy e.g. corticosteroids, retinoids, immunosuppressants, within four weeks before start of trial treatment (use of inhaled steroids is permitted)
- Patients treated with phototherapy UVB, PUVA, Grenz rays, or X-rays within four weeks before start of trial treatment
- Patients with known clinically relevant allergic contact dermatitis of the hands, as demonstrated by a prior positive patch test, who have not made a reasonable effort to avoid relevant contact allergens
- patients presenting with a) psoriasis lesions (including palmo-plantar psoriasis, b) atopic dermatitis lesions requiring medicated treatment, c) acute (non-chronic) episodes of pompholyx/ dyshydrosis or of contact dermatitis d) active bacterial, fungal or viral infections of the hands
- Patients presenting with any other skin disease likely to interfere with the conduct of the study and/or the evaluation of the results
- Patients with any serious medical condition which, in the opinion of the investigator, may interfere with the safety or the evaluation of the study, including chronic heart failure, recent myocardial infarction (chest pain within the last 3 months with changes in ECG and/or increased cardiac enzymes), chronic renal failure, chronic liver failure, unstable hypothyroidism, chronic biliary disease, uncontrolled diabetes mellitus
- Patients known to be immunocompromised
- Patients with ALT and/or AST >2.5x ULN
- Patients with fasting triglyceridemia > 1,5x ULN
- Patients with cholesterol >1,5 x ULN and/or LDL/cholesterol > 1,5 x ULN
- Patients with hemoglobin <0,9 LLN
- Patients receiving drugs with a potential for drug-drug interaction such as systemic tetracyclines, ketoconazole, erythromycin or clarithromycin, simvastatin, or St. John’s wort within one week, or receiving systemic itraconazole within 2 weeks, before start of trial treatment.
- Patients receiving topical retinoids, macrolides, tacrolimus, or pimecrolimus on affected areas, or taking vitamin supplements containing > 2000 IU vitamin A within one week before start of trial treatment
- Patients included in the study of an investigational drug within 2 months before start of trial treatment
- Patients with an active major psychiatric disorder (e.g. Major Depressive Disorder, Generalized Anxiety Disorder, Bipolar Disorder (I or II), or schizophrenia)

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To assess the safety of alitretinoin ;Primary end point(s): To assess the safety of alitretinoin by means of descriptive analysis of Adverse Events, laboratory data, CES-D and GHQ questionnaires and x-ray/DXA.;Secondary Objective: To determine the efficacy of the alitretinoin in patients with severe refractory CHaD, based on:<br>- proportion of patients with response (Physician's Global Assessment rating of clear or almost clear;<br>- proportion of patients with at least partial response (Physician's Global Assessment rating of clear, almost clear or mild);<br>- modified Total Lesion Symptom Score (mTLSS),<br>- Patient's Global Assessment (PaGA),<br>- Patient Defined Outcome (PaDO),<br>- extent of disease,<br>- intensity of pain and pruritus,

Secondary Outcome Measures