Atopic DermatitisNCT01402414
Narrow-band (NB)-UVB vs. Bath-PUVA and NB-UVB Plus Salt Water Baths in Atopic Dermatitis
A study testing NB-UVB, Bath-PUVA and NB-UVB plus salt water baths in people with Atopic Dermatitis, run by Ruhr University of Bochum at 1 site in Germany.
Trial summary
In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- NB-UVB, Bath-PUVA and NB-UVB plus salt water baths
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Apr 2011to Feb 2014
- Phase
- Interventional
- 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
- Patients with moderate to severe disease AD with SASSAD-Score > 25
- Age > 18 years
- No topical steroids or topical/systemic antibiotics within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion
Who cannot join
- Pregnancy or lactation
- Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
- Photo-skin type I according to Fitzpatrick
- severe cardiovascular disease
- intense UV radiation (tanning beds, sun exposure, phototherapy, etc.) 8 weeks before the start of the study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Department of Dermatology, Ruhr University Bochum
Bochum, North Rhine-Westphalia, 44791
About this study
Official title: Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis
In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.
Read the detailed description
Atopic dermatitis (AD) is a very common skin disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and psychological factors contribute to the pathogenesis of AD. However, among these factors, CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in AD. Different broadband (BB) UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined treatment modalities such as balneophototherapy and PUVA have previously been proven to be effective in AD. A small controlled study has previously demonstrated that the combination of UVB/UVA and saltwater baths is superior to phototherapy alone. Previous data from uncontrolled studies also speak for the effectiveness of systemic psoralen plus UVA (PUVA) therapy. A controlled crossover study has shown that systemic PUVA therapy is clearly superior to UVA1 phototherapy both in terms of clinical score (SCORAD) and reduction of response time. Systemic PUVA has in relation to bath PUVA significantly greater adverse effects (eg, nausea, liver enzyme elevation, photocarcinogenesis). A direct comparison between NB-UVB and bath PUVA has only been studied by a half-side comparison in a small number of patients. Both therapies were proved equally effective. In a recent study, it has been shown a clear advantage of NB-UVB plus salt water baths in comparison to NB-UVB alone. Tolerability was comparable; both treatments showed to be safe.
A randomized observer-blinded controlled crossover trial is conducted in which patients with AD receive a 4-week course of both NB-UVB and bath-PUVA or NB-UVB plus salt water baths. Clinical efficacy is assessed using the Six Area, Six Sign, Atopic Dermatitis (SASSAD) score and a visual analogue scale for pruritus. Assessment of health-related quality of life was performed using the Skindex-29. Moreover, immunohistochemical, RT-PCR and serological studies are planned.
- Conditions
- Atopic Dermatitis
- Being tested
- NB-UVB, Bath-PUVA, NB-UVB plus salt water baths
- Keywords
- atopic dermatitis, NB-UVB, phototherapy, balneophototherapy, Bath-PUVA, SCORAD index
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NB-UVBRadiation
The SB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the SB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.
Bath-PUVARadiation
Bath PUVA is performed with 8-Methoxypsoralen baths (concentration of ultimately 0.5 mg / l ) at 37 ° C with a bath time of 20 minutes and subsequent UVA irradiation (Waldmann cabine, 320-400 nm). The first dose is 70% of MPD, followed by 20% increase. The latter takes place at the earliest after 72 hours. The UV irradiations are carried out four times a week over a period of 4 weeks.
NB-UVB plus salt water bathsRadiation
First, a 20-minute bath in 3% salt water (Dead Sea salt, 37 ° C) is taken. Thereafter, a NB-UVB irradiation is performed. The UV radiation can be administered according to established protocols. The NB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks.
| Study group | Role | What they receive |
|---|---|---|
| NB-UVB | Active comparator | NB-UVB irradiations adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. Receives: Radiation: NB-UVB |
| Bath-PUVA | Active comparator | Phototherapy with UVA irradiation following bathing in psoralen water Receives: Radiation: Bath-PUVA |
| NB-UVB plus salt water baths | Active comparator | Balneophototherapy with NB-UVB and 3% Dead Sea salt water baths Receives: Radiation: NB-UVB plus salt water baths |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical improvement after treatments using a validated SASSAD index
Clinical improvement after treatments using a validated SASSAD index
Measured: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Secondary outcomes (3)
Evaluation of pruritus and sleeplessness visual analogue scales
Evaluation of pruritus and sleeplessness using visual analogue scales with 0 being no complaints and 10 being the worst complaints imaginable
Measured: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Measuring quality of life using the Skindex-29
Measuring patient's satisfaction / safety and quality of life using a qualified questionnaire: the Skindex-29.
Measured: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Immunohistochemical, RT-PCR and serological parameters
Measuring several immunohistochemical, RT-PCR and serological parameters in skin and blood, respectively.
Measured: Evaluation at baseline and after 4-week treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startApr 2011
- Primary completionFeb 2014
- Study completionFeb 2014
Why it stopped: Difficulties with the Recruitement
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.
- 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ruhr University of Bochum
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Sarah Terras, Ruhr University of Bochum
- Investigators
- Thilo Gambichler, adjunct professor, Principal investigator, Ruhr University Bochum
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402414
- Sponsor's protocol ID
- RUB-126
- Status last verified
- Feb 2014
- First submitted
- 19 Jul 2011
- Last updated
- 21 Feb 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Feb 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study Comparing the Effectiveness of Narrow-band UVB vs. Bath-PUVA and Narrow-band UVB + Salt Water Baths in Atopic Dermatitis
- ClinicalTrials.gov ID
- NCT01402414
- Acronym / sponsor ID
- RUB-126
- Conditions
- Atopic Dermatitis
- Keywords
- atopic dermatitis, NB-UVB, phototherapy, balneophototherapy, Bath-PUVA, SCORAD index
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Difficulties with the Recruitement
- Enrolment
- 10 participants (actual)
- Lead sponsor
- Ruhr University of BochumUniversity, hospital or other
- Study start
- Apr 2011
- Primary completion
- Feb 2014 (actual)
- Study completion
- Feb 2014 (actual)
- First posted
- 26 Jul 2011 (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.
In this controlled crossover study we aim to compare the efficacy of narrow-band UVB (NB-UVB) with bath-PUVA and NB-UVB plus salt water baths in atopic dermatitis.
Detailed description
Atopic dermatitis (AD) is a very common skin disorder that is characterized by pruritic inflammatory skin lesions, with patients usually having an individual or family history of atopic diseases in their background (e.g., allergic asthma and rhinitis). Defective skin barrier, immunological dysfunctions (type I and IV allergy), genetic disorders, and psychological factors contribute to the pathogenesis of AD. However, among these factors, CD4+ Th cells are reported to play a particularly crucial role in the pathogenesis of AD. Phototherapy is among the first-line approaches in the management of AD. In this context, a variety of studies have shown a beneficial effect of natural or artificial UV radiation in AD. Different broadband (BB) UV spectra (BB-UVA, BB-UVB, BB-UVA/BB-UVB) and combined treatment modalities such as balneophototherapy and PUVA have previously been proven to be effective in AD. A small controlled study has previously demonstrated that the combination of UVB/UVA and saltwater baths is superior to phototherapy alone. Previous data from uncontrolled studies also speak for the effectiveness of systemic psoralen plus UVA (PUVA) therapy. A controlled crossover study has shown that systemic PUVA therapy is clearly superior to UVA1 phototherapy both in terms of clinical score (SCORAD) and reduction of response time. Systemic PUVA has in relation to bath PUVA significantly greater adverse effects (eg, nausea, liver enzyme elevation, photocarcinogenesis). A direct comparison between NB-UVB and bath PUVA has only been studied by a half-side comparison in a small number of patients. Both therapies were proved equally effective. In a recent study, it has been shown a clear advantage of NB-UVB plus salt water baths in comparison to NB-UVB alone. Tolerability was comparable; both treatments showed to be safe.
A randomized observer-blinded controlled crossover trial is conducted in which patients with AD receive a 4-week course of both NB-UVB and bath-PUVA or NB-UVB plus salt water baths. Clinical efficacy is assessed using the Six Area, Six Sign, Atopic Dermatitis (SASSAD) score and a visual analogue scale for pruritus. Assessment of health-related quality of life was performed using the Skindex-29. Moreover, immunohistochemical, RT-PCR and serological studies are planned.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (investigator)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| NB-UVB | Active comparator | Radiation: NB-UVBNB-UVB irradiations adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. |
| Bath-PUVA | Active comparator | Radiation: Bath-PUVAPhototherapy with UVA irradiation following bathing in psoralen water |
| NB-UVB plus salt water baths | Active comparator | Radiation: NB-UVB plus salt water bathsBalneophototherapy with NB-UVB and 3% Dead Sea salt water baths |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with moderate to severe disease AD with SASSAD-Score > 25
- Age > 18 years
- No topical steroids or topical/systemic antibiotics within the last 2 weeks, no systemic glucocorticosteroids or other immunosuppressive agents within the last 8 weeks, no phototherapy within the last 12 weeks before inclusion
Key exclusion criteria (5 listed)
- Pregnancy or lactation
- Skin cancer or dysplastic naevi, photosensitive skin diseases, autoimmune diseases or relevant cardiovascular diseases
- Photo-skin type I according to Fitzpatrick
- severe cardiovascular disease
- intense UV radiation (tanning beds, sun exposure, phototherapy, etc.) 8 weeks before the start of the study
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 |
|---|---|---|
| NB-UVBThe SB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the SB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks. | Radiation | NB-UVB |
| Bath-PUVABath PUVA is performed with 8-Methoxypsoralen baths (concentration of ultimately 0.5 mg / l ) at 37 ° C with a bath time of 20 minutes and subsequent UVA irradiation (Waldmann cabine, 320-400 nm). The first dose is 70% of MPD, followed by 20% increase. The latter takes place at the earliest after 72 hours. The UV irradiations are carried out four times a week over a period of 4 weeks. | Radiation | Bath-PUVA |
| NB-UVB plus salt water bathsFirst, a 20-minute bath in 3% salt water (Dead Sea salt, 37 ° C) is taken. Thereafter, a NB-UVB irradiation is performed. The UV radiation can be administered according to established protocols. The NB-UVB irradiations (Cosmedico, Villingen-Schwenningen) are adapted to the NB-MED-UVB (70%) started and increased by 10-20% per session. The UV irradiations are carried out four times a week over a period of 4 weeks. | Radiation | NB-UVB plus salt water baths |
Primary outcome
Clinical improvement after treatments using a validated SASSAD index
Time frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Clinical improvement after treatments using a validated SASSAD index
3 secondary outcomes
Evaluation of pruritus and sleeplessness visual analogue scales
Time frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Measuring quality of life using the Skindex-29
Time frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up
Immunohistochemical, RT-PCR and serological parameters
Time frame: Evaluation at baseline and after 4-week treatment
Results and safety
The study was stopped early (reason given: Difficulties with the Recruitement). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Feb 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.
Thilo Gambichler, adjunct professor principal investigator
Ruhr University Bochum
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NB-UVB, Bath-PUVA and NB-UVB plus salt water baths in people with Atopic Dermatitis, run by Ruhr University of Bochum 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 3 inclusion and 5 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 21 Feb 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.
Are results available for this study?
The study was stopped early (reason given: Difficulties with the Recruitement). 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?
Clinical improvement after treatments using a validated SASSAD index (time frame: Evaluation at baseline and after 4-week treatment, 3 months follow-up). 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 21 Feb 2014.