Plaque PsoriasisNCT02098213
Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis
A study testing Immediate spa treatment and Late Spa treatment in people with Plaque Psoriasis, run by Association Francaise pour la Recherche Thermale at 5 sites in France.
Trial summary
Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Plaque Psoriasis
- What is being tested?
- Immediate spa treatment and Late Spa treatment
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 128 participants
- Where
- 5 sitesFrance
- Study dates
- Jan 2015to Dec 2019
- 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
- Both sexes, over 18 years of age, patients with plaque psoriasis for more than one year diagnosed by a dermatologist
- Stable treatment in the last 6 months
- DLQI score > 10
- patients volunteering for spa treatment within 6 weeks
- consenting to participate to the study with informed consent form signed after appropriate information
- Affiliation to the French social security system or equivalent
Who cannot join
- Pregnancy, parturient or breast feeding
- Psychiatric illness or social situation that would preclude study compliance
- Refusal of consent
- Refusal of spa treatment
- Contra-indication to spa treatment
- Phototherapy in the last 3 months
Show all 9Show fewer
- Guttate, pustular or erythrodermic psoriasis Isolated nail psoriasis
- Spa therapy in the past year
- Person deprived of liberty or under legal guardianship
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
France5 sites
Station Thermale Avene
Avène, Languedoc-Rousillon, 34260
Thermes La Roche Posay
La Roche-Posay, Poitou-Charentes, 86270
Les thermes de ST-GERVAIS
Le Fayet, Rhône-Alpe, 74190
Thermes de Molitg les bains
Molitg-les-Bains, Languedoc-Roussillon, 66500
Etablissement thermal d'Uriage
Uriage-les-Bains, Rhône-Alpe, 38410
About this study
Official title: Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study
Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.
Read the detailed description
Psoriasis is one of the most common skin diseases, affecting 2-3% of the general population; more than 1 million people in France.
This auto-immune erythematosquamous inflammatory dermatosis occurs on a particular genetic background and has a chronic course. Psoriasis has a history as an indication for dermatological spa treatment (water cures in the Dead Sea). As these treatments are a combination of balneotherapy and heliotherapy, many recent studies have attempted to assess the value and position the relative benefit of each therapeutic element. Over the last four decades various different phototherapy techniques have been widely used in the treatment of psoriasis. The thermal option for many psoriasis patients depends on personal choice, or their doctor's or dermatologist's recommendation. In 1994 only one third of the 16,875 spa treatments for dermatological conditions (about 5625 cures) were for psoriasis, suggesting that spa treatment is underused as a treatment for psoriasis. Nobody can challenge the therapeutic contribution of biotherapy in the treatment of anatomically destructive diseases such as rheumatoid arthritis and psoriatic arthritis, but the use of these treatments is not without risk and economic impact. There is thus a need for less intensive treatments that have little risk of serious side effects and are less expensive.
The use of spa therapy in psoriasis should be understood as complementary and not an alternative to all other treatments. The choice of treatment is guided by the patient's characteristics and pathology (concomitant diseases, extent of lesions, treatment history) and the specialty (adverse effects, cumulative dose). In psoriasis it may be necessary to use different lines of treatment because psoriasis is a lifetime disease. Side effects of systemic treatments such as biotherapy, cyclosporine, methotrexate, synthetic retinoids, and also phototherapy (PUVA and UVB) are cumulative over time. A course of spa treatment should allow a respite before resorting to other systemic therapy.
However, the spa dermatology still suffers from a lack of large-scale evaluation and especially an objective assessment using reliable methodologies that limit bias. This is the purpose of this study.
There are no randomized controlled multicenter clinical trials evaluating spa treatment for psoriasis, although an Italian non-randomized study included a few dozen patients and confirmed the clinical benefit of the treatment.
- Conditions
- Plaque Psoriasis
- Being tested
- Immediate spa treatment, Late Spa treatment
- Keywords
- plaque psoriasis, DLQI, VQ Dermato, PASI, PASI change, phototherapy, balneotherapy, hydrotherapy, Euroquol EQ 5d scale, Visual analogic scale, SPA treatment Scale, PSS
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Immediate spa treatmentOther
Also called Spa treatment soon after randomisation
soon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
Late Spa treatmentOther
Also called Spa treatment after 4,5 months visit in the study
soon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc)
| Study group | Role | What they receive |
|---|---|---|
| Immediate Spa treatment | Active comparator | Three week course of spa treatment soon after randomization Receives: Other: Immediate spa treatment |
| Late Spa treatment | Sham comparator | Three week course of spa treatment soon after 4,5 months visit Receives: Other: Late Spa treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dermatology Quality of Life Index (DQLI)
proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.
Measured: 4 ½ months after randomisation
Secondary outcomes (9)
Specific Quality Of Life
proportion of patients in each arm of the study (spa treatment versus usual care) for the following specific dermatology questionnaires : DLQI score ≤ 10 at 6, 9 and 12 months and VQ Dermato score > 35 at 4 1/2, 6, 9 and 12 months
Measured: 4 1/2, 6, 9 and 12 months after randomisation
Global Quality Of Life
EuroQOL 5D questionnaire at 4 1/2, 6, 9 and 12 months
Measured: 4 1/2, 6, 9 and 12 months after randomisation
Clinical benefit of the psoriasis
proportion of patients with a PASI (Psoriasis Area and Severity Index) 50 and PASI 75 at 4½, 6, 9 and 12 months in each arm of the study, spa treatment versus usual care.
Measured: 4 1/2, 6, 9 and 12 months after randomisation
pain and pruritus
Self-administered questionnaire with Visual Analogue Scale for pain and for pruritus at 4 1/2, 6, 9, 12 months
Measured: 4 1/2, 6, 9 and 12 months after randomisation
Treatment follow up
- Assessment of topical treatments within 12 months (number of tubes used per month)
- Number of phototherapy sessions
- Use of conventional systemic therapies (acitretin, methotrexate, cyclosporine) (number of weeks of treatment and dosage)
- Number of weeks of treatment by biotherapy
- Reduction in the use of the health care system (Number of hospitalizations and specialized consultations in connection with psoriasis or not) within 12 months
- Reports on the use of complementary and alternative medicines within12 months
Measured: 4 1/2, 6, 9 and 12 months after randomisation
patient's examination
Impact of the spa treatment on overall metabolism indicators in the year
Will be collected at 4 1/2, 6, 9 and 12 months in the two groups:
- height an weight (BMI calculation)
- Waist measurement
- Blood pressure
Measured: 4 1/2, 6, 9 and 12 months after randomisation
Safety evaluation
Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials
Measured: 4 1/2, 6, 9 and 12 months after randomisation
Stress evaluation
self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only
Measured: 4 1/2, 6, 9 and 12 months after randomisatio
Long term evaluation
Evaluation of the maintenance of benefits at 12 months (stability of the long term effect) on the primary outcome and secondary outcomes.
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Mar 2014 (estimated)
- Study startJan 2015
- Primary completion15 May 2019
- Study completionDec 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (20)Papers the sponsor has linked to this study.
- Other trials for Plaque PsoriasisStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Taking into account the hypothesis of a proportion of patients with a DLQI≤10 (absence of repercussion or low impact of psoriasis on quality of life) of 25% at 4 months 1/2 in the arm immediate spa treatment versus 10% in the usual care group (late spa treatment), 113 patients per group is required, with an alpha 5% risk and a power of 80 %. Given the risk of potential patients lost to follow-up estimates of 15%, we plan to include 130 patients per randomisation group, so 260 patients in total. According to the protocol submitted to authorities, given the uncertainties of necessary hypothesis, a re-evaluation of the number of subjects required after the first 100 inclusions is planned. This reassessment will be carried out without intermediate analysis but in view of the results observed for the primary endpoint in mean and standard deviation (event driven).
- Masking
- None (open label)
- Enrolment
- 128 participants (actual)
Sponsor and investigators
- Lead sponsor
- Association Francaise pour la Recherche Thermale
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Grenoble, Floralis
- Responsible party
- Sponsor
- Investigators
- Marie MB BEYLOT-BARRY, Professor, Principal investigator, Bordeaux University Hospital - France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02098213
- Sponsor's protocol ID
- PSOTHERMES
- Status last verified
- Jan 2020
- First submitted
- 17 Mar 2014
- Last updated
- 9 Jan 2020
- Results posted
- No
- Data monitoring committee
- No
Publications
Halverstam CP, Lebwohl M. Nonstandard and off-label therapies for psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):546-53. doi: 10.1016/j.clindermatol.2007.10.023.
PubMed 18755374Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001.
PubMed 18755366ALT J, NONCLERCQ E. [Treatment of psoriasis by ultraviolet and photosensitizers]. Bull Soc Fr Dermatol Syphiligr. 1953 Jul-Oct;60(4):343-5. No abstract available. Undetermined Language.
PubMed 13115903Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. No abstract available. French.
PubMed 5454618Oddoze L, Temime P, Marchand JP, Benne M. [Combined oral meladinine and ultraviolet rays in the treatment of psoriasis. (Preliminary note)]. Bull Soc Fr Dermatol Syphiligr. 1967;74(5):609-10. No abstract available. French.
PubMed 5587899SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available.
PubMed 13229486Young E. Ultraviolet therapy of psoriasis: a critical study. Br J Dermatol. 1972 Oct;87(4):379-82. doi: 10.1111/j.1365-2133.1972.tb07426.x. No abstract available.
PubMed 4562168van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. doi: 10.1046/j.1365-2230.2001.00829.x.
PubMed 11422189Weinstein GD, White GM. An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol. 1993 Mar;28(3):454-9. doi: 10.1016/0190-9622(93)70067-4.
PubMed 8445062Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. doi: 10.1016/s0190-9622(03)01144-7.
PubMed 12894135Tabolli S, Calza A, Di Pietro C, Sampogna F, Abeni D. Quality of life of psoriasis patients before and after balneo -- or balneophototherapy. Yonsei Med J. 2009 Apr 30;50(2):215-21. doi: 10.3349/ymj.2009.50.2.215.
PubMed 19430554Grob JJ, Auquier P, Martin S, Lancon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The ReseaudEpidemiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22. doi: 10.1159/000018250.
PubMed 10592400Hsu S, Papp KA, Lebwohl MG, Bagel J, Blauvelt A, Duffin KC, Crowley J, Eichenfield LF, Feldman SR, Fiorentino DF, Gelfand JM, Gottlieb AB, Jacobsen C, Kalb RE, Kavanaugh A, Korman NJ, Krueger GG, Michelon MA, Morison W, Ritchlin CT, Stein Gold L, Stone SP, Strober BE, Van Voorhees AS, Weiss SC, Wanat K, Bebo BF Jr; National Psoriasis Foundation Medical Board. Consensus guidelines for the management of plaque psoriasis. Arch Dermatol. 2012 Jan;148(1):95-102. doi: 10.1001/archdermatol.2011.1410.
PubMed 22250239Pathirana D, Ormerod AD, Saiag P, Smith C, Spuls PI, Nast A, Barker J, Bos JD, Burmester GR, Chimenti S, Dubertret L, Eberlein B, Erdmann R, Ferguson J, Girolomoni G, Gisondi P, Giunta A, Griffiths C, Honigsmann H, Hussain M, Jobling R, Karvonen SL, Kemeny L, Kopp I, Leonardi C, Maccarone M, Menter A, Mrowietz U, Naldi L, Nijsten T, Ortonne JP, Orzechowski HD, Rantanen T, Reich K, Reytan N, Richards H, Thio HB, van de Kerkhof P, Rzany B. European S3-guidelines on the systemic treatment of psoriasis vulgaris. J Eur Acad Dermatol Venereol. 2009 Oct;23 Suppl 2:1-70. doi: 10.1111/j.1468-3083.2009.03389.x.
PubMed 19712190Basra MK, Fenech R, Gatt RM, Salek MS, Finlay AY. The Dermatology Life Quality Index 1994-2007: a comprehensive review of validation data and clinical results. Br J Dermatol. 2008 Nov;159(5):997-1035. doi: 10.1111/j.1365-2133.2008.08832.x. Epub 2008 Sep 15.
PubMed 18795920
Study at a glance
From the registry record, last updated by the sponsor on 9 Jan 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study
- ClinicalTrials.gov ID
- NCT02098213
- Acronym / sponsor ID
- PSOTHERMES
- Conditions
- Plaque Psoriasis
- Keywords
- plaque psoriasis, DLQI, VQ Dermato, PASI, PASI change, phototherapy, balneotherapy, hydrotherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 128 participants (actual)
- Lead sponsor
- Association Francaise pour la Recherche ThermaleUniversity, hospital or other
- Collaborators
- University Hospital, Grenoble, Floralis
- Study start
- Jan 2015 (actual)
- Primary completion
- 15 May 2019 (actual)
- Study completion
- Dec 2019 (actual)
- First posted
- 27 Mar 2014 (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.
Assessment of quality of life after Spa therapy (4 ½ months follow-up) in the treatment of plaque psoriasis: Spa versus usual care in patients with plaque psoriasis.
Detailed description
Psoriasis is one of the most common skin diseases, affecting 2-3% of the general population; more than 1 million people in France.
This auto-immune erythematosquamous inflammatory dermatosis occurs on a particular genetic background and has a chronic course. Psoriasis has a history as an indication for dermatological spa treatment (water cures in the Dead Sea). As these treatments are a combination of balneotherapy and heliotherapy, many recent studies have attempted to assess the value and position the relative benefit of each therapeutic element. Over the last four decades various different phototherapy techniques have been widely used in the treatment of psoriasis. The thermal option for many psoriasis patients depends on personal choice, or their doctor's or dermatologist's recommendation. In 1994 only one third of the 16,875 spa treatments for dermatological conditions (about 5625 cures) were for psoriasis, suggesting that spa treatment is underused as a treatment for psoriasis. Nobody can challenge the therapeutic contribution of biotherapy in the treatment of anatomically destructive diseases such as rheumatoid arthritis and psoriatic arthritis, but the use of these treatments is not without risk and economic impact. There is thus a need for less intensive treatments that have little risk of serious side effects and are less expensive.
The use of spa therapy in psoriasis should be understood as complementary and not an alternative to all other treatments. The choice of treatment is guided by the patient's characteristics and pathology (concomitant diseases, extent of lesions, treatment history) and the specialty (adverse effects, cumulative dose). In psoriasis it may be necessary to use different lines of treatment because psoriasis is a lifetime disease. Side effects of systemic treatments such as biotherapy, cyclosporine, methotrexate, synthetic retinoids, and also phototherapy (PUVA and UVB) are cumulative over time. A course of spa treatment should allow a respite before resorting to other systemic therapy.
However, the spa dermatology still suffers from a lack of large-scale evaluation and especially an objective assessment using reliable methodologies that limit bias. This is the purpose of this study.
There are no randomized controlled multicenter clinical trials evaluating spa treatment for psoriasis, although an Italian non-randomized study included a few dozen patients and confirmed the clinical benefit of the treatment.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Taking into account the hypothesis of a proportion of patients with a DLQI≤10 (absence of repercussion or low impact of psoriasis on quality of life) of 25% at 4 months 1/2 in the arm immediate spa treatment versus 10% in the usual care group (late spa treatment), 113 patients per group is required, with an alpha 5% risk and a power of 80 %. Given the risk of potential patients lost to follow-up estimates of 15%, we plan to include 130 patients per randomisation group, so 260 patients in total. According to the protocol submitted to authorities, given the uncertainties of necessary hypothesis, a re-evaluation of the number of subjects required after the first 100 inclusions is planned. This reassessment will be carried out without intermediate analysis but in view of the results observed for the primary endpoint in mean and standard deviation (event driven).
| Arm | Type | Receives |
|---|---|---|
| Immediate Spa treatment | Active comparator | Other: Immediate spa treatmentThree week course of spa treatment soon after randomization |
| Late Spa treatment | Sham comparator | Other: Late Spa treatmentThree week course of spa treatment soon after 4,5 months visit |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Both sexes, over 18 years of age, patients with plaque psoriasis for more than one year diagnosed by a dermatologist
- Stable treatment in the last 6 months
- DLQI score > 10
- patients volunteering for spa treatment within 6 weeks
- consenting to participate to the study with informed consent form signed after appropriate information
Key exclusion criteria (9 listed)
- Pregnancy, parturient or breast feeding
- Psychiatric illness or social situation that would preclude study compliance
- Refusal of consent
- Refusal of spa treatment
- Contra-indication to spa treatment
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 |
|---|---|---|
| Immediate spa treatmentAlso: Spa treatment soon after randomisationsoon after randomization: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all participating of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc) | Other | Immediate Spa treatment |
| Late Spa treatmentAlso: Spa treatment after 4,5 months visit in the studysoon after 4,5 months visit: Spa treatment of 3 weeks. Spa treatment : that best adapted to the concerned pathology and common to all of spa resorts (walk in a specially pool, whirlpool bath with automatic air and water massages cycles, massaging shower etc) | Other | Late Spa treatment |
Primary outcome
Dermatology Quality of Life Index (DQLI)
Time frame: 4 ½ months after randomisation
proportion of patients with a score ≤ 10 at 4½ months in each arm of the study, spa treatment versus usual care.
9 secondary outcomes
Specific Quality Of Life
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Global Quality Of Life
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Clinical benefit of the psoriasis
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
pain and pruritus
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Treatment follow up
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
patient's examination
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Safety evaluation
Time frame: 4 1/2, 6, 9 and 12 months after randomisation
Stress evaluation
Time frame: 4 1/2, 6, 9 and 12 months after randomisatio
Long term evaluation
Time frame: 12 months
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 9 Jan 2020.
- Background: PubMed 18755374Halverstam CP, Lebwohl M. Nonstandard and off-label therapies for psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):546-53. doi: 10.1016/j.clindermatol.2007.10.023.
- Background: PubMed 18755366Kazandjieva J, Grozdev I, Darlenski R, Tsankov N. Climatotherapy of psoriasis. Clin Dermatol. 2008 Sep-Oct;26(5):477-85. doi: 10.1016/j.clindermatol.2008.05.001.
- Background: PubMed 13115903ALT J, NONCLERCQ E. [Treatment of psoriasis by ultraviolet and photosensitizers]. Bull Soc Fr Dermatol Syphiligr. 1953 Jul-Oct;60(4):343-5. No abstract available. Undetermined Language.
- Background: PubMed 5454618Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. No abstract available. French.
- Background: PubMed 5587899Oddoze L, Temime P, Marchand JP, Benne M. [Combined oral meladinine and ultraviolet rays in the treatment of psoriasis. (Preliminary note)]. Bull Soc Fr Dermatol Syphiligr. 1967;74(5):609-10. No abstract available. French.
- Background: PubMed 13229486SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. No abstract available.
- Background: PubMed 4562168Young E. Ultraviolet therapy of psoriasis: a critical study. Br J Dermatol. 1972 Oct;87(4):379-82. doi: 10.1111/j.1365-2133.1972.tb07426.x. No abstract available.
- Background: PubMed 11422189van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. doi: 10.1046/j.1365-2230.2001.00829.x.
- Background: PubMed 8445062Weinstein GD, White GM. An approach to the treatment of moderate to severe psoriasis with rotational therapy. J Am Acad Dermatol. 1993 Mar;28(3):454-9. doi: 10.1016/0190-9622(93)70067-4.
- Background: PubMed 12894135Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. doi: 10.1016/s0190-9622(03)01144-7.
- Background: PubMed 19430554Tabolli S, Calza A, Di Pietro C, Sampogna F, Abeni D. Quality of life of psoriasis patients before and after balneo -- or balneophototherapy. Yonsei Med J. 2009 Apr 30;50(2):215-21. doi: 10.3349/ymj.2009.50.2.215.
- Background: PubMed 10592400Grob JJ, Auquier P, Martin S, Lancon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The ReseaudEpidemiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22. doi: 10.1159/000018250.
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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.
Marie MB BEYLOT-BARRY, Professor principal investigator
Bordeaux University Hospital - France
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Immediate spa treatment and Late Spa treatment in people with Plaque Psoriasis, run by Association Francaise pour la Recherche Thermale at 5 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 6 inclusion and 9 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 9 Jan 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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.
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?
Dermatology Quality of Life Index (DQLI) (time frame: 4 ½ months after randomisation). 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 NCT02098213, which also lists 20 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 9 Jan 2020.