Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis

This pilot, phase II, 24-week study will recruit a total of 10 patients and will evaluate the efficacy and safety of acitretin in patients with severe chronic hand dermatitis .

Study Overview

• Status: Completed
• Conditions: Chronic Hand Dermatitis
• Intervention / Treatment: Drug: Acitretin

Detailed Description

Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, will be increased in the first 4 weeks to a maximum of 30 mg/day.

• Study Type: Interventional
• Enrollment (Actual): 9
• Phase: Phase 2; Phase 3

Contacts and Locations

Study Locations

• Canada
  • Ontario
    • Windsor, Ontario, Canada, N8W 5L7
      • Windsor Clinical Research Inc.
  • Quebec
    • Montreal, Quebec, Canada, H2K 4L5
      • Innovaderm Research Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Men or post-menopausal or surgically sterile women, 18 years of age or older at time of consent
• Has stable chronic hand dermatitis for at least 6 months
• Has chronic hand dermatitis with a PGA of severe at Day 0
• Unless vasectomized for at least 6 months or clinically diagnosed infertile, if male patient has a female partner of childbearing potential, patient and patient's partner are willing to use effective contraceptive method for at least 30 days before screening and until 2 years after the study. Male patient should not father a child or donate sperm during the study and for 2 years after the last treatment.

Effective contraceptive methods are:

• Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream
• Female partner: Hormonal contraception (oral, intramuscular, implant or transdermal) which include Depo-Provera, Evra and Nuvaring. Oral contraceptives must have been taken at a stable dose for at least 90 days before study start

• Female partner: Intrauterine device (IUD)

  • Female patient has a negative serum pregnancy test within 14 days of Day 0
  • Capable of giving informed consent and the consent must be obtained prior to any study related procedures.

Exclusion Criteria:

• Female of childbearing potential, pregnant or lactating
• Has any other skin disease that could impair his/her safety during the study or interfere with the evaluation of the results
• Has a known allergy to acitretin, other retinoids or vitamin A derivates, or to any component of the study product
• Has used acitretin within 24 weeks of Day 0
• Has used systemic retinoid (including alitretinoin) within 6 months of Day 0
• Has used tetracycline or other vitamin supplements containing vitamin A within 4 weeks of Day 0
• Has used methotrexate within 6 months of Day 0
• Has used systemic therapy (e.g. corticosteroids, immunosuppressants or phototherapy) within four weeks of Day 0. Inhaled corticosteroids for stable medical conditions are allowed
• Has used any topical treatment for had dermatitis (e.g. retinoids, corticosteroids, tacrolimus, pimecrolimus) on the hands within 14 days of Day 0. If patients are using topical treatments for dermatitis on other areas of the body, it must be applied with gloves.
• Has used investigational agent within 30 days prior to Day 0, or within 5 half-lives of the investigational agent prior to day 0 (whichever is longer)
• Has a history of alcoholism or drug abuse within 12 months prior to Day 0
• Is planning to donate blood within 2 years after the end of the study
• Clinically significant increase in hepatic enzymes, cholesterol or triglyceride at screening that would, in the opinion of the investigator, put patient at risk if he/she receives acitretin
• Diagnosis or symptoms of inflammatory bowel diseases at screening or baseline
• Has an unstable or serious medical condition as defined by the investigator or presence of any significant medical condition, including severe renal impairment, that might cause this study to be detrimental to the patient
• Diagnosis or symptoms of active depression, including depression currently under control with medication, at screening or baseline

Study Plan

How is the study designed?

Design Details

• Primary Purpose: TREATMENT
• Allocation: NA
• Interventional Model: SINGLE_GROUP
• Masking: NONE

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

EXPERIMENTAL: Acitretin; Patients will receive acitretin once daily for a maximum of 24 weeks. Patients who reach a Physician Global Assessment (PGA) of clear or almost clear at week 12 will end the study. Patients who do not reach a PGA of clear or almost clear at week 12 will continue treatment up to week 24. The starting dose will be 10mg/day and, if well tolerated, it will be increased in the first 4 weeks to a maximum of 30 mg/day.

Drug: Acitretin; All patients will receive open-label single oral acitretin 10 mg capsule once daily as a starting dose. If well tolerated, the dose will be increased in the first 4 weeks to a maximum of 30mg/day. Patients will be instructed to take the treatment as a single oral dose with a meal.; Other Names: Soriatane

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy.	12-24 weeks

Secondary Outcome Measures

Outcome Measure	Time Frame
Proportion of patients who reach a partial response defined as a PGA of clear, almost clear or mild at the end of therapy	12-24 weeks
Change from baseline in modified Total Lesion Symptom Score (mTLSS) at the end of therapy	12-24 weeks
Mean time to response defined as the number of days between baseline and the time the patient reaches a PGA of clear or almost clear	24 weeks
Mean Patient Global Assessment (PaGA) at the end of therapy	12-24 weeks
Change from baseline in extent of disease at the end of therapy	12-24 weeks
Type, severity and relationship of adverse events	12-24 weeks

Collaborators and Investigators

• Sponsor: Innovaderm Research Inc.
• Collaborators: Tribute Pharmaceuticals
• Investigators: Study Director: Jerry Tan, MD, FRCPC, Windsor Clinical Research Inc

Study record dates

Study Major Dates

• Study Start: March 1, 2012
• Primary Completion (ACTUAL): January 1, 2014
• Study Completion (ACTUAL): January 1, 2014

Study Registration Dates

• First Submitted: February 29, 2012
• First Submitted That Met QC Criteria: February 29, 2012
• First Posted (ESTIMATE): March 6, 2012

Study Record Updates

• Last Update Posted (ESTIMATE): July 24, 2014
• Last Update Submitted That Met QC Criteria: July 23, 2014
• Last Verified: July 1, 2014

More Information

Terms related to this study

• Keywords: acitretin; PGA; chronic hand dermatitis
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Dermatologic Agents; Keratolytic Agents; Acitretin
• Other Study ID Numbers: Inno-6022