An Open-label Controlled Trial: Effectiveness of Balneotherapy in Palmoplantar Psoriasis and Contact Dermatitis.

NCT06458868 | Completed DMC

• 1 other identifier: BALNEOTERAPİ
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

Patients who had an indication for phototherapy were included in this study. The treatment was used as a monotherapy protocol. The standard protocol for bathing PUVA involved applying 0.01% bath psoralen for 15 minutes, while the tap water group only received a tap water bath for 15 minutes and the salt water group received 3% salted (NaCl) water before UVA treatment. Main tools to assess the efficacy is disease activity scores and quaity of Life scores.

Conditions

Psoriasis; Contact Dermatitis of Hand

Keywords

bath puva; uva; psorolene; phototherapy; local uv a

Outcome Measures

Primary Outcomes (1)

• Disease Severity Reduction

  At least %50 reduction of the disease severity with the intervention groups at 36th week of the treatment

  Disease Severity

Secondary Outcomes (1)

• Improvevement in the Quality of Life

  Qol

Study Arms (3)

bath puva

NO INTERVENTION

Patients received the standard protocol of bath PUVA with standard psoralen plus tap water in combination with a phototherapy regimen.

salt water uva

EXPERIMENTAL

Patients received saline solution (3% NaCl) in addition to UVA with standard phototherapy regimen.

Other: salt water or tap water before UVA

tap water uva

EXPERIMENTAL

Patients received tap water in addition to UVA with standard phototherapy regimen.

Other: salt water or tap water before UVA

Interventions

salt water or tap water before UVA OTHER

Instead of using standard bath PUVA, this study investigates the efficacy of tap water or salt water with UVA in the treatment of palmoplantar psoriasis.

salt water uva; tap water uva

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals aged between 18 and 65
• Clinical diagnosis of Palmoplantar Psoriasis or Contact Dermatitis

You may not qualify if:

• Individuals under 18 or over 65
• Pregnancy or breastfeeding
• History of malignancy
• Diagnosis of photodermatosis
• Prescription or use of photoallergenic or phototoxic drugs

Sponsors & Collaborators

• Ankara University: lead

Study Sites (1)

Ankara University School of Medicine

Ankara, 06100, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Nihal Kundakcı, Prof

  Ankara University Faculty of Medicine, Department of Dermatology and Venereology

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: Endpoint assessors blinded
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Doctor

Model Details: Prospective single center open label three parallel group, adaptive randomized controlled trial

Study Record Dates

• First Submitted: May 29, 2024
• First Posted: June 14, 2024
• Study Start: June 1, 2014
• Primary Completion: May 10, 2017
• Study Completion: October 1, 2023
• Last Updated: December 27, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

TU (1)