Chronic Hand DermatitisPhase 2/3NCT01545284
Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis
A Phase 2/3 study testing Acitretin in people with Chronic Hand Dermatitis, run by Innovaderm Research Inc. at 2 sites in Canada.
Trial summary
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 . Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Hand Dermatitis
- What is being tested?
- Acitretin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 9 participants
- Where
- 2 sitesCanada
- Study dates
- Mar 2012to Jan 2014
- Phase
- Phase 2/3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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
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- 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
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Innovaderm Research Inc.
Montreal, Quebec, H2K 4L5
Windsor Clinical Research Inc.
Windsor, Ontario, N8W 5L7
About this study
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 .
Read the 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.
- Conditions
- Chronic Hand Dermatitis
- Being tested
- Acitretin
- Keywords
- chronic hand dermatitis, acitretin, PGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AcitretinDrug
Also called Soriatane
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.
| Study group | Role | What they receive |
|---|---|---|
| Acitretin | Experimental | 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. Receives: Drug: Acitretin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy.
Measured: 12-24 weeks
Secondary outcomes (6)
Proportion of patients who reach a partial response defined as a PGA of clear, almost clear or mild at the end of therapy
Measured: 12-24 weeks
Change from baseline in modified Total Lesion Symptom Score (mTLSS) at the end of therapy
Measured: 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
Measured: 24 weeks
Mean Patient Global Assessment (PaGA) at the end of therapy
Measured: 12-24 weeks
Change from baseline in extent of disease at the end of therapy
Measured: 12-24 weeks
Type, severity and relationship of adverse events
Measured: 12-24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2012 (estimated)
- Study startMar 2012
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Hand DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 9 participants (actual)
Sponsor and investigators
- Lead sponsor
- Innovaderm Research Inc.
- Sponsor type
- University, hospital or other
- Collaborators
- Tribute Pharmaceuticals
- Responsible party
- Sponsor
- Investigators
- Robert Bissonnette, MD, FRCPC, Principal investigator, Innovaderm Research Inc.Jerry Tan, MD, FRCPC, Study director, Windsor Clinical Research Inc
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01545284
- Sponsor's protocol ID
- Inno-6022
- Status last verified
- Jul 2014
- First submitted
- 29 Feb 2012
- Last updated
- 24 Jul 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pilot Study on the Use of Acitretin for the Treatment of Severe Chronic Hand Dermatitis
- ClinicalTrials.gov ID
- NCT01545284
- Acronym / sponsor ID
- Inno-6022
- Conditions
- Chronic Hand Dermatitis
- Keywords
- chronic hand dermatitis, acitretin, PGA
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 9 participants (actual)
- Lead sponsor
- Innovaderm Research Inc.University, hospital or other
- Collaborators
- Tribute Pharmaceuticals
- Study start
- Mar 2012
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 6 Mar 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 .
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Acitretin | Experimental | Drug: AcitretinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
- Barrier methods such as condom, sponge or diaphragm combined with spermicide in foam, gel or cream
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AcitretinAlso: SoriataneAll 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. | Drug | Acitretin |
Primary outcome
Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy.
Time frame: 12-24 weeks
6 secondary outcomes
Proportion of patients who reach a partial response defined as a PGA of clear, almost clear or mild at the end of therapy
Time frame: 12-24 weeks
Change from baseline in modified Total Lesion Symptom Score (mTLSS) at the end of therapy
Time frame: 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
Time frame: 24 weeks
Mean Patient Global Assessment (PaGA) at the end of therapy
Time frame: 12-24 weeks
Change from baseline in extent of disease at the end of therapy
Time frame: 12-24 weeks
Type, severity and relationship of adverse events
Time frame: 12-24 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert Bissonnette, MD, FRCPC principal investigator
Innovaderm Research Inc.
Jerry Tan, MD, FRCPC study director
Windsor Clinical Research Inc
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Acitretin in people with Chronic Hand Dermatitis, run by Innovaderm Research Inc. at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Proportion of patients who reach a Physician Global Assessment (PGA) of clear or almost clear at the end of therapy. (time frame: 12-24 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2014.