Atopic DermatitisPhase 4TocyDDNCT01231854
Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis.
A Phase 4 study testing Ciclosporin and Alitretinoin in people with Atopic Dermatitis, run by Technische Universität Dresden at 1 site in Germany.
Trial summary
The purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Ciclosporin and Alitretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteGermany
- Study dates
- Nov 2010to Mar 2013
- Phase
- Phase 4
- 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
- Male and female Patients age > 18 years and ≤ 75 years
- Body weight 50 to 100 kg
- Chronic hand dermatitis (duration > 6 months)
- Atopic constitution according to
- Erlanger Atopiescore1 and/or
- positive personal history for atopic eczema, allergic rhinitis, allergic asthma and/or
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- elevated serum IgE
- Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA
- Written informed consent
Who cannot join
- Participation in other clinical trial within past 4 weeks
- Pregnancy/breastfeeding
- Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination:
- post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml),
- postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
- Regular and proper use of at least two methods of contraception, including at least one method of contraception with a failure rate <1% per year (eg, implants, depot preparations, oral contraceptives, IUD).
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- vasectomy of the partner.
- Women within reproductive age, who do not meet all of the following criteria throughout the whole study or - in case of early study termination - up to 5 weeks after active therapy:
- The patient understands the teratogenic risk associated with taking the study medication.
- The patient understands the need for strict monthly monitoring, the need for a reliable, continuous contraception and the need for regular pregnancy tests throughout the study and - in case of early study termination - up to 5 weeks of active therapy.
- The patient is able to adequately and reliably apply methods of contraception.
- The patient is informed about the possible consequences of pregnancy and knows that she must immediately contact her physician in case of suspected pregnancy.
- The patient gives informed consent about knowing the potential risks and necessary measures to avoid pregnancy.
- Blood and/or plasma donation during the whole study period. In case of early study termination blood and plasma donation is not allowed until 1 month after the end of active study treatment
- UV-therapy within past 3 months
- Concurrent photo-and / or photochemotherapy
- Known Hypersensitivity / Intolerance against ciclosporin, alitretinoin or any other ingredients of Immunosporin® or Toctino®
- Known Allergy against peanuts or soya
- Known Hereditary fructose intolerance
- Acute and/or uncontrolled chronic infectious disease
- Known Congenital or acquired immune deficiency
- Malignant tumor (past or present)
- Uncontrolled arterial hypertension (RR systolic ≥ 160 mm Hg and/or RR diastolic≥ 90 mm Hg despite anti-hypertensive treatment)
- Renal insufficiency (Serum creatinine above normal range)
- Liver insufficiency (CHILD ≥ Stadium B)
- Not sufficiently controlled hyperlipidemia (LDL/HDL ratio > 4 despite medical treatment)
- Clinically significant thyroid hypofunction
- Known Hypervitaminosis A
- Concurrent supplementation of vitamin A or treatment with other retinoids
- Concurrent tetracycline therapy
- Concurrent therapy with St. John's wort ("Johanniskraut")
- Known genetic diseases causing increased UV light sensitivity such as Xeroderma pigmentosum, Cockayne-syndrome, Bloom syndrome
- Known Drug- and/or alcohol abuse
- Known significant psychiatric morbidity
Trial locations and contacts
1 site in 1 country.
Germany1 site
Universitätsklinikum Carl Gustav Carus an der TU Dresden
Dresden, Saxony, 01307
About this study
Official title: Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.
The purpose of this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.
- Conditions
- Atopic Dermatitis
- Being tested
- Ciclosporin, Alitretinoin
- Keywords
- atopic hand dermatitis, Chronic hand dermatitis
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiclosporinDrug
Also called Immunosporin
In accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg).
AlitretinoinDrug
Also called Toctino
In accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg.
| Study group | Role | What they receive |
|---|---|---|
| Ciclosporingroup | Active comparator | Not described Receives: Drug: Ciclosporin |
| Alitretinoingroup | Active comparator | Not described Receives: Drug: Alitretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
Secondary outcomes (11)
Time to complete or almost complete clearance according to IGA in both groups
Proportion of patients with complete or almost complete clearance according to the Patients Global Assessment (PGA) within 12 weeks and 24 weeks of active therapy
Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
Mean utilization of topical steroids within the follow-up period in both groups
Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
In patients with atopic dermatitis on the body: measured percentage of patients with at least 50% improvement in disease severity with the active therapy using the SCORAD.
Tolerability and safety in both study groups
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2010 (estimated)
- Study startNov 2010
- Primary completionMar 2012
- Study completionMar 2013
Why it stopped: delayed start of the trial, both treatment options already have market authorizations, study medication expired
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Technische Universität DresdenThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Technische Universität Dresden
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01231854
- Sponsor's protocol ID
- TUD-TOCYDD-044
- Other IDs
- 2009-017520-88, 2009
- Acronym
- TocyDD
- Status last verified
- Jun 2014
- First submitted
- 29 Oct 2010
- Last updated
- 3 Jun 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Ciclosporin Versus Alitretinoin for Severe Atopic Hand Dermatitis. A Randomized Controlled Investigator-initiated Double-blind Trial.
- ClinicalTrials.gov ID
- NCT01231854
- Acronym / sponsor ID
- TocyDD / TUD-TOCYDD-044
- Conditions
- Atopic Dermatitis
- Keywords
- atopic hand dermatitis, Chronic hand dermatitis
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: delayed start of the trial, both treatment options already have market authorizations, study medication expired
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Technische Universität DresdenUniversity, hospital or other
- Study start
- Nov 2010
- Primary completion
- Mar 2012 (actual)
- Study completion
- Mar 2013 (actual)
- First posted
- 1 Nov 2010 (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 this study is to investigate the comparative efficacy, safety and efficiency of ciclosporin microemulsion and alitretinoin in adults with severe atopic hand dermatitis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciclosporingroup | Active comparator | Drug: Ciclosporin |
| Alitretinoingroup | Active comparator | Drug: Alitretinoin |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- Male and female Patients age > 18 years and ≤ 75 years
- Body weight 50 to 100 kg
- Chronic hand dermatitis (duration > 6 months)
- Atopic constitution according to
- Severe hand dermatitis not responding to treatment with potent topical steroids for at least 4 weeks within the past 6 months due to IGA
Key exclusion criteria (34 listed)
- Participation in other clinical trial within past 4 weeks
- Pregnancy/breastfeeding
- Women within reproductive age except those women who fulfil at least one of the following criteria throughout the total study and until at least 5 weeks after active study treatment in case of early study termination:
- post-menopausal women (12 months physiological amenorrhoea or 6 months amenorrhoea with serum FSH level > 40 mlU/ml),
- postoperative (6 weeks after bilateral ovariectomy with or without hysterectomy)
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 |
|---|---|---|
| CiclosporinAlso: ImmunosporinIn accordance with the current guideline concerning the use of ciclosporin in dermatology and the current guideline management of hand eczema the daily oral dosage of ciclosporin microemulsion is 2.7 to 4.0 mg/kg bodyweight (half of the total daily dosage will be administered in the morning and in the evening). To enable both body-weight adjusted treatment and double-blind treatment patients will be allocated to 2 different dosages depending on their body weight (50-74.9 kg: daily dosage 200 mg; 75-100 kg: daily dosage 300 mg). | Drug | Ciclosporingroup |
| AlitretinoinAlso: ToctinoIn accordance with the current guideline management of hand eczema alitretinoin will be administered orally in a constant daily dosage of 30 mg. | Drug | Alitretinoingroup |
Primary outcome
Proportion of patients with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.
11 secondary outcomes
Time to complete or almost complete clearance according to IGA in both groups
Proportion of patients with complete or almost complete clearance according to the Patients Global Assessment (PGA) within 12 weeks and 24 weeks of active therapy
Mean relative change in objective disease severity (HECSI) between baseline and week 4, 8, 12, 16, 20, 24 in both groups
Mean relative change in quality of life (Skindex 17) between baseline and week 24 in both groups
Cost-effectiveness of the studied treatment options (cost / QALY gained; assessed by means of the (EQ-5D)
Mean relative change in work productivity (assessed by means of the work limitations questionnaire (WLQ) in both groups
Mean utilization of topical steroids within the follow-up period in both groups
Patient satisfaction with treatment in both groups (assessed using a 100mm VAS Scale)
Proportion of patients with relapse (≥ 75% of baseline HECSI) within 24-week follow-up after previous complete/almost complete clearance
In patients with atopic dermatitis on the body: measured percentage of patients with at least 50% improvement in disease severity with the active therapy using the SCORAD.
Tolerability and safety in both study groups
Results and safety
The study was stopped early (reason given: delayed start of the trial, both treatment options already have market authorizations, study medication expired). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciclosporin and Alitretinoin in people with Atopic Dermatitis, run by Technische Universität Dresden 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 9 inclusion and 34 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: stopped early, as of the sponsor's last update on 3 Jun 2014. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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 was stopped early (reason given: delayed start of the trial, both treatment options already have market authorizations, study medication expired). Results are not available in the source record.
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 with complete or almost complete clearance according to the Investigator Global Assessment (IGA) within 24-week active therapy in both groups.. 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 3 Jun 2014.