Hand DermatosesPhase 3NCT00124475
Efficacy and Safety of a Retinoid for the Treatment of Severe Chronic Hand Dermatitis
A Phase 3 study testing alitretinoin in people with Hand Dermatoses, run by Basilea Pharmaceutica at 1 site in Germany.
Trial summary
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Hand Dermatoses
- What is being tested?
- alitretinoin
- How many people
- 1,035 participants
- Where
- 1 siteGermany
- Study dates
- Dec 2004to Sep 2007
- Phase
- Phase 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
- Lasting for 6 months since initial diagnosis
- Rated severe
- Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
- Refractory to topical steroids
Who cannot join
- Female patients who are pregnant or want to become pregnant
- Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
- Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
Read the detailed description
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.
Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.
- Conditions
- Hand Dermatoses
- Being tested
- alitretinoin
- Keywords
- Chronic Hand Dermatitis
- Medical subject headings
- Hand Dermatoses
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
alitretinoinDrug
What is being measured
The primary outcome is the main question the study is designed to answer.
Physicians global assessment
at week 12 or 24
Secondary outcomes (5)
Response rate per treatment group
Modified total lesion symptom score
Patients global assessment
at week 12 or 24
Time to relapse
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jul 2005 (estimated)
- Study startDec 2004
- Primary completionOct 2006
- Study completionSep 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hand DermatosesStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Enrolment
- 1,035 participants
Sponsor and investigators
- Lead sponsor
- Basilea Pharmaceutica
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Thomas Ruzicka, MD, Principal investigator, University of Düsseldorf, Dermatological Hospital, Germany
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00124475
- Sponsor's protocol ID
- BAP00089
- Status last verified
- May 2023
- First submitted
- 26 Jul 2005
- Last updated
- 10 May 2023
- Results posted
- No
Publications
Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
PubMed 15611422
Study at a glance
From the registry record, last updated by the sponsor on 10 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of BAL4079 in the Treatment of Severe Refractory Chronic Hand Dermatitis
- ClinicalTrials.gov ID
- NCT00124475
- Acronym / sponsor ID
- BAP00089
- Conditions
- Hand Dermatoses
- Keywords
- Chronic Hand Dermatitis
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,035 participants
- Lead sponsor
- Basilea PharmaceuticaIndustry (pharma, biotech, devices)
- Study start
- Dec 2004
- Primary completion
- Oct 2006 (actual)
- Study completion
- Sep 2007 (actual)
- First posted
- 28 Jul 2005 (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.
The purpose of the study is to determine the therapeutic effect of alitretinoin, a retinoid, on severe, therapy refractory chronic hand dermatitis.
Detailed description
Chronic hand dermatitis (CHaD) is a frequent and distressing disease. Conventional treatments yield mostly unsatisfactory results. In addition, chronic hand dermatitis leads to 2-5% of all applications for permanent disability pensions in some western countries. In a therapeutic dose finding study alitretinoin was clinically effective for patients with moderate to severe chronic hand dermatitis refractory to topical treatment.
Patients with severe refractory CHaD will be allocated either of two active treatments or placebo. The primary objective is to demonstrate the response rate based on physicians global assessment of the disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Chronic hand dermatitis, all types including hyperkeratotic, vesicular, fingertip dermatitis
- Lasting for 6 months since initial diagnosis
- Rated severe
- Refractory to standard therapy including non-medicated therapy and avoidance of irritants and allergens
- Refractory to topical steroids
Key exclusion criteria (3 listed)
- Female patients who are pregnant or want to become pregnant
- Female patients of child bearing potential who cannot use or will not commit to using two effective forms of contraception simultaneously
- Patients whose disease is adequately controlled by standard non-medicated therapy and standard corticosteroid therapy
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 |
|---|---|---|
| alitretinoin | Drug | – |
Primary outcome
Physicians global assessment
at week 12 or 24
5 secondary outcomes
Response rate per treatment group
Modified total lesion symptom score
Patients global assessment
at week 12 or 24
Time to relapse
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 10 May 2023.
- Background: PubMed 15611422Ruzicka T, Larsen FG, Galewicz D, Horvath A, Coenraads PJ, Thestrup-Pedersen K, Ortonne JP, Zouboulis CC, Harsch M, Brown TC, Zultak M. Oral alitretinoin (9-cis-retinoic acid) therapy for chronic hand dermatitis in patients refractory to standard therapy: results of a randomized, double-blind, placebo-controlled, multicenter trial. Arch Dermatol. 2004 Dec;140(12):1453-9. doi: 10.1001/archderm.140.12.1453.
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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.
Thomas Ruzicka, MD principal investigator
University of Düsseldorf, Dermatological Hospital, Germany
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing alitretinoin in people with Hand Dermatoses, run by Basilea Pharmaceutica at 1 site in Germany.
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 5 inclusion and 3 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 10 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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 phase mean?
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?
Physicians global assessment. The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00124475, which also lists 1 linked publication.
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 10 May 2023.