NCT02713711

Brief Summary

The purpose of this study is to compare the effectiveness of artificial balneotherapy (AB), phototherapy (PT) and artificial balneophototherapy (BPT) in the treatment of plaque psoriasis, evaluating the plaque area, alteration of skin pigmentation, Psoriasis Area and Severity Index (PASI) score determination and quality-of-life assessment by Short Form 36 Health Survey (SF-36) and Psoriasis Disability Index (PDI) scores during the month of treatment. Methods: Experimental study, prospective, randomized, single-blind. 14 subjects participated from the city of Talca, Chile medically diagnosed with psoriasis, more than one plaque in the skin without topical treatment voluntarily. All subjects completed the study that consisted of 12 sessions.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
14

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Shorter than P25 for not_applicable

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2013

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

March 10, 2016

Completed
11 days until next milestone

First Posted

Study publicly available on registry

March 21, 2016

Completed
4.9 years until next milestone

Results Posted

Study results publicly available

February 15, 2021

Completed
Last Updated

February 15, 2021

Status Verified

January 1, 2021

Enrollment Period

6 months

First QC Date

March 10, 2016

Results QC Date

October 31, 2016

Last Update Submit

January 25, 2021

Conditions

Psoriasis

Keywords

Psoriasisbalneotherapyphototherapybalneophototherapy

Outcome Measures

Primary Outcomes (1)

  • Percentage Change in Psoriatic Plaque Area

    The plaques were photographed at a distance of 20 cm with a 12 pixel Lumix digital camera (Panasonic, USA). For area quantification, the photographs were taken before session 1 and a day after session 6 and 12, and were analyzed with ImageJ software (version 1.46j; National Institute of Health, MD, USA). A single area value was calculated per psoriatic plaque after twelve sessions (percentage of decrease).

    Before first session (day 1), after the six session (day 12) and after the twelve session (day 26)

Secondary Outcomes (4)

  • Arbitrary Units Change in Psoriatic Plaque Erythema

    Before first session (day 1) and after the twelve session (day 26)

  • Number of Participants With Change in PASI From Baseline to Session 12

    Before first session (day 1) and after the twelve session (day 26)

  • Number of Participants With Change in Quality of Life

    Before first session (day 1) and after the twelve session (day 26)

  • Number of Participants With Change in Psoriasis Disability

    Session 1 and session 12

Study Arms (4)

control group

NO INTERVENTION

The control group plaques did not receive any treatment.

phototherapy group

EXPERIMENTAL

Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).

Radiation: phototherapy

balneotherapy

EXPERIMENTAL

Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.

Procedure: balneotherapy

balneophototherapy

EXPERIMENTAL

Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.

Procedure: balneophototherapy

Interventions

phototherapyRADIATION

Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).

phototherapy group
balneotherapyPROCEDURE

Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).

balneotherapy
balneophototherapyPROCEDURE

Twelve sessions of both balneotherapy and phototherapy treatments.

balneophototherapy

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • be more than 18 years-old,
  • have more than one plaque on the skin,
  • medically diagnosed as plaque psoriasis over a year ago and,
  • without concurrent topical treatment for Psoriasis (by own choice).

You may not qualify if:

  • pregnancy,
  • skin carcinoma,
  • severe diabetes mellitus,
  • uncontrolled chronic pathologies and/or severe cardiac/renal insufficiency and/or acute infections.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Psoriasis

Interventions

PhototherapyBalneology

Condition Hierarchy (Ancestors)

Skin Diseases, PapulosquamousSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Results Point of Contact

Title
Professor Gabriel Nasri Marzuca Nassr
Organization
UC de Maule
gmarzuca@gmail.com
56 71 203463

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
PT; MSc

Study Record Dates

First Submitted

March 10, 2016

First Posted

March 21, 2016

Study Start

December 1, 2013

Primary Completion

June 1, 2014

Study Completion

June 1, 2014

Last Updated

February 15, 2021

Results First Posted

February 15, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share