Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis

Plaque Psoriasis Clinical Trial

Official title:

Evaluation of Spa Therapy in the Treatment of Plaque Psoriasis, a Randomized, Controlled, Open Multicenter Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02098213
• Other study ID #: PSOTHERMES
• Status: Completed
• Phase: N/A
• Start date: January 2015
• Est. completion date: December 2019

Study information

• Verified date: January 2020
• Source: Association Francaise pour la Recherche Thermale
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 128
• Est. completion date: December 2019
• Est. primary completion date: May 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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

• Guttate, pustular or erythrodermic psoriasis Isolated nail psoriasis

• Spa therapy in the past year

• Person deprived of liberty or under legal guardianship

Related Conditions & MeSH terms

• Plaque Psoriasis
• Psoriasis

Intervention

Other:
• Immediate spa treatment
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 treatment
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)

Locations

Country	Name	City	State
France	Station Thermale Avene	Avene	Languedoc-Rousillon
France	Thermes La Roche Posay	La Roche Posay	Poitou-Charentes
France	Les thermes de ST-GERVAIS	Le Fayet	Rhône-Alpe
France	Thermes de Molitg les bains	Molitg	Languedoc-Roussillon
France	Etablissement thermal d'Uriage	Uriage	Rhône-Alpe

Sponsors (3)

Lead Sponsor	Collaborator
Association Francaise pour la Recherche Thermale	Floralis, University Hospital, Grenoble

Country where clinical trial is conducted

France, 

References & Publications (19)

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Basra 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. Review. — View Citation

Fredriksson T, Pettersson U. Severe psoriasis--oral therapy with a new retinoid. Dermatologica. 1978;157(4):238-44. — View Citation

Grob JJ, Auquier P, Martin S, Lançon C, Bonerandi JJ. Development and validation of a quality of life measurement for chronic skin disorders in french: VQ-Dermato. The RéseaudEpidémiolo gie en Dermatologie. Dermatology. 1999;199(3):213-22. — View Citation

Grupper C, Bourgeois-Spinasse J, Eisenmann D. [Treatment of psoriasis in 1970]. Cah Med. 1970 Sep;11:Suppl:15-20. French. — View Citation

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. Review. — View Citation

Hsu 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. — View Citation

Kazandjieva 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. Review. — View Citation

Lebwohl M. Combining the new biologic agents with our current psoriasis armamentarium. J Am Acad Dermatol. 2003 Aug;49(2 Suppl):S118-24. Review. — View Citation

Oddoze L, Témime 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. French. — View Citation

Pathirana 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, Hönigsmann 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. Erratum in: J Eur Acad Dermatol Venereol. 2010 Jan;24(1):117-8. — View Citation

Shikiar R, Bresnahan BW, Stone SP, Thompson C, Koo J, Revicki DA. Validity and reliability of patient reported outcomes used in psoriasis: results from two randomized clinical trials. Health Qual Life Outcomes. 2003 Oct 8;1:53. — View Citation

Shikiar R, Willian MK, Okun MM, Thompson CS, Revicki DA. The validity and responsiveness of three quality of life measures in the assessment of psoriasis patients: results of a phase II study. Health Qual Life Outcomes. 2006 Sep 27;4:71. — View Citation

SOLOMON WM, NETHERTON EW, NELSON PA, ZEITER WJ. Treatment of psoriasis with Goeckerman technic. Arch Phys Med Rehabil. 1955 Feb;36(2):74-7. — View Citation

Tabolli 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. — View Citation

Tsai TF, Ho JC, Song M, Szapary P, Guzzo C, Shen YK, Li S, Kim KJ, Kim TY, Choi JH, Youn JI; PEARL Investigators. Efficacy and safety of ustekinumab for the treatment of moderate-to-severe psoriasis: a phase III, randomized, placebo-controlled trial in Taiwanese and Korean patients (PEARL). J Dermatol Sci. 2011 Sep;63(3):154-63. doi: 10.1016/j.jdermsci.2011.05.005. Epub 2011 May 20. — View Citation

van de Kerkhof PC. Therapeutic strategies: rotational therapy and combinations. Clin Exp Dermatol. 2001 Jun;26(4):356-61. Review. — View Citation

Weinstein 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. — View Citation

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* Note: There are 19 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	4 ½ months after randomisation
Secondary	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	4 1/2, 6, 9 and 12 months after randomisation
Secondary	Global Quality Of Life	EuroQOL 5D questionnaire at 4 1/2, 6, 9 and 12 months	4 1/2, 6, 9 and 12 months after randomisation
Secondary	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.	4 1/2, 6, 9 and 12 months after randomisation
Secondary	pain and pruritus	Self-administered questionnaire with Visual Analogue Scale for pain and for pruritus at 4 1/2, 6, 9, 12 months	4 1/2, 6, 9 and 12 months after randomisation
Secondary	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	4 1/2, 6, 9 and 12 months after randomisation
Secondary	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	4 1/2, 6, 9 and 12 months after randomisation
Secondary	Safety evaluation	Evaluation of all adverse events attributable to treatment, or not, according to the usual criteria of pharmacovigilance in clinical trials	4 1/2, 6, 9 and 12 months after randomisation
Secondary	Stress evaluation	self administered questionnaire (PSS: Assessment of stress) at inclusion in the study only	4 1/2, 6, 9 and 12 months after randomisatio
Secondary	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.	12 months