Atopic DermatitisPhase 2PRADANCT02537509
PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter Coupled With Oral Vitamin D Supplementation vs. Placebo
A Phase 2 study testing Cholecalciferol in people with Atopic Dermatitis, run by Rennes University Hospital at 11 sites in France.
Trial summary
Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients Read more about this study
- Who is it for?
- Ages 15 years and older
- Conditions the study is for
- Atopic Dermatitis
- What is being tested?
- Cholecalciferol
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 111 participants
- Where
- 11 sitesFrance
- Study dates
- 27 Oct 2015to 3 Mar 2023
- Phase
- Phase 2
- 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 15 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with atopic dermatitis (Hanifin and Rajka criteria),
- Aged 15 years or more,
- With > 2 years of disease evolution,
- With moderate-to-severe disease (IGA > 2),
- Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
- Seasonality in disease severity (based on a questionnaire assessing disease improvement during summer),
Show all 10Show fewer
- Easy access to a phototherapy cabin (widely implanted in primary care dermatology private practice in France),
- Effective contraception to be used at least 30 days before initiation of treatment, during treatment and 29 weeks after last administration for women of reproductive age,
- Written informed consent of the patient
- For patients aged between 15 and 18, written informed consent of the parents and of the teenager.
Who cannot join
- Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
- Clinical suspicion of hypercalciuria,
- Indication to a systemic immunosuppressant in the next 2 years,
- Atopic dermatitis known to be aggravated by UV exposure,
- Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2),
- More than 100 previous phototherapy sessions in lifetime,
- Pregnancy or breastfeeding,
- Persons subject to major legal protection (safeguarding justice, guardianship, trusteeship), persons deprived of liberty.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
France11 sites
Hôpital Saint André
Bordeaux, 33075
Hôpital Morvan
Brest, 29609
Hôpital Trousseau
Chambray-lès-Tours, 37170
Centre Hospitalier
Le Mans, 72000
CHU de Nantes - Hôtel Dieu
Nantes, 44093
APHP - Hôpital Tenon
Paris, 75020
Centre Hospitalier
Périgueux, 24000
Hôpital Laënnec
Quimper, 29107
Hôpital Pontchaillou
Rennes, 35033
CHR St Brieuc
Saint-Brieuc, 22000
Centre Hospitalier
Valenciennes, 59322
About this study
Official title: Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial
Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients
Read the detailed description
The major therapeutic challenge in patient with Atopic Dermatitis is long-term control of disease activity (LTC), for which the current TAT-based pro-active strategy does not meet all the needs.
Phototherapy is a good candidate: it is widely used as a second-line treatment in AD with demonstrated efficacy. However, only short-term control has been evaluated; and only 2-3 times a week intensive schedules have been tested and are used in current practice. A novel phototherapy regimen would be required for disease LTC, allowing a trade-off between disease control, UV-induced risks, and patient adherence.
Vitamin D supplementation is another good candidate: several studies have shown lower serum levels of vitamin D to be correlated with more severe AD; and three short-term, low-power low-quality, placebo-controlled randomised trials testing vitamin D supplementation yielded conflicting results, leaving its therapeutic efficacy undecided for short-term control, and unknown for LTC.
- Conditions
- Atopic Dermatitis
- Being tested
- Cholecalciferol, Placebo of cholecalciferol
- Medical subject headings
- Dermatitis, Atopic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CholecalciferolDrug
Also called Uvedose
Placebo of cholecalciferolDrug
Also called Placebo of Uvedose
| Study group | Role | What they receive |
|---|---|---|
| Cholecalciferol | Active comparator | Administration of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite) Receives: Drug: Cholecalciferol |
| Placebo of cholecalciferol | Placebo comparator | Administration of placebo of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite) Receives: Drug: Placebo of cholecalciferol |
What is being measured
The primary outcome is the main question the study is designed to answer.
Hierarchical criterion based on repeated measures of PO-SCORAD severity score
Measurement of PO-SCORAD score
Measured: 2 years
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
Measurement of cumulative consumption of topical anti-inflammatory treatments
Measured: 2 years
Secondary outcomes (10)
Assessment of desease severity
Assessment of desease severity by EASI score
Measured: 2 years
Assessment of desease severity
Assessment of desease severity by IGA score
Measured: 2 years
Assessment of desease severity
Assessment of desease severity by SCORAD score
Measured: 2 years
Assessment of desease severity
Assessment of desease severity by POEM score
Measured: 2 years
Assessment of the quality of life
Assessment of the quality of life by DLQI score
Measured: 2 years
Measurement of serum Vitamin D (25-(OH)-vitamin D)
Measured: 2 years
Measurement of total IgE serum
Measured: 2 years
Assessement of number of weeks of well-controlled atopic dermatitis
Measured: 2 years
Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments
Measured: 2 years
Assessment of patient satisfaction
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2015 (estimated)
- Study start27 Oct 2015
- Primary completion3 Mar 2023
- Study completion3 Mar 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Catherine Droitcourt, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02537509
- Sponsor's protocol ID
- 2015-000881-73
- Other IDs
- 35RC14_9754_PRADA, 2015
- Acronym
- PRADA
- Status last verified
- Mar 2023
- First submitted
- 28 Aug 2015
- Last updated
- 23 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
Publications
Droitcourt C, Barbarot S, Visseiche V, Maruani A, Dinulescu M, Darrieux L, Misery L, Brenaut E, Soria A, Vermersch A, Maillard H, Seneschal J, Taieb A, Chabbert C, Adamski H, Dupuy A, Oger E. A New Phototherapy Regimen Coupled with Oral Vitamin D Supplementation, for the Long-Term Control of Atopic Dermatitis: A French Multicenter, Randomized, Crossover, Pragmatic Trial. Dermatol Ther (Heidelb). 2026 Sep 11. doi: 10.1007/s13555-026-01914-8. Online ahead of print.
PubMed 42728529Droitcourt C, Barbarot S, Maruani A, Darrieux L, Misery L, Brenaut E, Adamski H, Chabbert C, Vermersch A, Weiborn M, Seneschal J, Taieb A, Plantin P, Maillard H, Phan A, Skowron F, Viguier M, Staumont-Salle D, Nosbaum A, Soria A, Barbaud A, Oger E, Dupuy A; Groupe de Recherche sur l'Eczema Atopique de la Societe Francaise de Dermatologie (GREAT). A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial. Trials. 2019 Mar 25;20(1):184. doi: 10.1186/s13063-019-3276-9.
PubMed 30909923
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicentre, Cross-over, PRAgmatic Trial in Atopic Dermatitis Testing Long-term Control Effectiveness of New Phototherapy Regimen During Winter as an add-on Therapy, Coupled With Oral Vitamin D Supplementation vs. Placebo in a Randomised, Parallel-group Trial
- ClinicalTrials.gov ID
- NCT02537509
- Acronym / sponsor ID
- PRADA / 2015-000881-73
- Conditions
- Atopic Dermatitis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- 27 Oct 2015 (actual)
- Primary completion
- 3 Mar 2023 (actual)
- Study completion
- 3 Mar 2023 (actual)
- First posted
- 1 Sep 2015 (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.
Spaced phototherapy sessions during winter as add-on therapy in combination with vitamin D supplementation or not, could be beneficial to improve disease LTC in AD patients
Detailed description
The major therapeutic challenge in patient with Atopic Dermatitis is long-term control of disease activity (LTC), for which the current TAT-based pro-active strategy does not meet all the needs.
Phototherapy is a good candidate: it is widely used as a second-line treatment in AD with demonstrated efficacy. However, only short-term control has been evaluated; and only 2-3 times a week intensive schedules have been tested and are used in current practice. A novel phototherapy regimen would be required for disease LTC, allowing a trade-off between disease control, UV-induced risks, and patient adherence.
Vitamin D supplementation is another good candidate: several studies have shown lower serum levels of vitamin D to be correlated with more severe AD; and three short-term, low-power low-quality, placebo-controlled randomised trials testing vitamin D supplementation yielded conflicting results, leaving its therapeutic efficacy undecided for short-term control, and unknown for LTC.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cholecalciferol | Active comparator | Drug: CholecalciferolAdministration of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite) |
| Placebo of cholecalciferol | Placebo comparator | Drug: Placebo of cholecalciferolAdministration of placebo of cholecalciferol every 3 months during 2 years combined with new phototherapy regimen during winter (phototherapy winter 1, observation winter 2 or the opposite) |
Who may qualify
- Ages
- 15 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (10 listed)
- Patients with atopic dermatitis (Hanifin and Rajka criteria),
- Aged 15 years or more,
- With > 2 years of disease evolution,
- With moderate-to-severe disease (IGA > 2),
- Patients that have received TAT for at least 12 weeks and have symptoms requiring an increase in therapy,
Key exclusion criteria (8 listed)
- Any cause of contra-indication for vitamin D supplementation: flare of granulomatosis, primary hyperparathyroidism,
- Clinical suspicion of hypercalciuria,
- Indication to a systemic immunosuppressant in the next 2 years,
- Atopic dermatitis known to be aggravated by UV exposure,
- Any contra-indication for artificial or solar exposure including: genetic diseases with a predisposition to skin cancer, any history of personal skin cancer (melanoma, squamous cell skin cancer, basal cell skin cancer), lupus, dermatomyositis, any other photosensitizing skin disease, photosensitizing medication (see appendix 2),
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 |
|---|---|---|
| CholecalciferolAlso: Uvedose | Drug | Cholecalciferol |
| Placebo of cholecalciferolAlso: Placebo of Uvedose | Drug | Placebo of cholecalciferol |
Primary outcome
Hierarchical criterion based on repeated measures of PO-SCORAD severity score
Time frame: 2 years
Measurement of PO-SCORAD score
Hierarchical criterion based on cumulative consumption of topical anti-inflammatory treatments (collected tubes) during winter
Time frame: 2 years
Measurement of cumulative consumption of topical anti-inflammatory treatments
10 secondary outcomes
Assessment of desease severity
Time frame: 2 years
Assessment of desease severity
Time frame: 2 years
Assessment of desease severity
Time frame: 2 years
Assessment of desease severity
Time frame: 2 years
Assessment of the quality of life
Time frame: 2 years
Measurement of serum Vitamin D (25-(OH)-vitamin D)
Time frame: 2 years
Measurement of total IgE serum
Time frame: 2 years
Assessement of number of weeks of well-controlled atopic dermatitis
Time frame: 2 years
Assessment of inter-visit cumulative consumption of topical anti-inflammatory treatments
Time frame: 2 years
Assessment of patient satisfaction
Time frame: 2 years
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 23 Mar 2023.
- Derived from this study: PubMed 42728529Droitcourt C, Barbarot S, Visseiche V, Maruani A, Dinulescu M, Darrieux L, Misery L, Brenaut E, Soria A, Vermersch A, Maillard H, Seneschal J, Taieb A, Chabbert C, Adamski H, Dupuy A, Oger E. A New Phototherapy Regimen Coupled with Oral Vitamin D Supplementation, for the Long-Term Control of Atopic Dermatitis: A French Multicenter, Randomized, Crossover, Pragmatic Trial. Dermatol Ther (Heidelb). 2026 Sep 11. doi: 10.1007/s13555-026-01914-8. Online ahead of print.
- Derived from this study: PubMed 30909923Droitcourt C, Barbarot S, Maruani A, Darrieux L, Misery L, Brenaut E, Adamski H, Chabbert C, Vermersch A, Weiborn M, Seneschal J, Taieb A, Plantin P, Maillard H, Phan A, Skowron F, Viguier M, Staumont-Salle D, Nosbaum A, Soria A, Barbaud A, Oger E, Dupuy A; Groupe de Recherche sur l'Eczema Atopique de la Societe Francaise de Dermatologie (GREAT). A new phototherapy regimen during winter as an add-on therapy, coupled with oral vitamin D supplementation, for the long-term control of atopic dermatitis: study protocol for a multicentre, randomized, crossover, pragmatic trial - the PRADA trial. Trials. 2019 Mar 25;20(1):184. doi: 10.1186/s13063-019-3276-9.
Related trials for Atopic Dermatitis
RecruitingPhase 1
Evaluating the Safety and Tolerability of Baricitinib in Patients With Job Syndrome With Lupus-Like Disease and/or Atopic Dermatitis
Hyper IgE Syndrome From STAT3 Mutation, Job s Syndrome
RecruitingPhase 2
Cardamom and Topical Roseomonas in Atopic Dermatitis
Atopic Dermatitis, Eczema
RecruitingObservational study
ADBest TREAT Registry
Atopic Dermatitis
RecruitingPhase 2
Effects of Treatments on Atopic Dermatitis
Eczema, Dermatitis
RecruitingObservational study
Natural History and Genetics of Food Allergy and Related Conditions
Food Allergy, Loeys-Dietz Syndrome
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.
Catherine Droitcourt principal investigator
Rennes University Hospital
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cholecalciferol in people with Atopic Dermatitis, run by Rennes University Hospital at 11 sites in France.
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 8 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 23 Mar 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in France. 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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?
Hierarchical criterion based on repeated measures of PO-SCORAD severity score (time frame: 2 years). 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 NCT02537509, which also lists 2 linked publications.
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 23 Mar 2023.