Trial Outcomes & Findings for Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis (NCT NCT02713711)

Results Overview

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).

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

14 participants

Primary outcome timeframe

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

Results posted on

2021-02-15

Participant Flow

Unit of analysis: psoriatic plaques

Participant milestones

Participant milestones
Measure	Control Group The control group plaques did not receive any treatment.	Phototherapy Group Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Overall Study STARTED	9 14	6 15	6 14	10 15
Overall Study COMPLETED	9 14	6 15	6 14	10 15
Overall Study NOT COMPLETED	0 0	0 0	0 0	0 0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Participants n=58 psoriatic plaques Each participant had psoriatic plaques divided into 4 groups. 1. The control group plaques did not receive any treatment. 2. Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). \- phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED). 3. Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. \- balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L). 4. Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. * balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	14 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Age, Continuous	37.85 years STANDARD_DEVIATION 9.85 • n=5 Participants
Sex: Female, Male Female	7 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Region of Enrollment Chile	14 participants n=5 Participants

PRIMARY outcome

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

Population: 14 subjects (7 female and 7 male) with 58 total psoriatic plaques divided in the 4 groups

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).

Outcome measures

Outcome measures
Measure	Control Group n=14 psoriatic plaques The control group plaques did not receive any treatment.	Phototherapy Group n=15 psoriatic plaques Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy n=14 psoriatic plaques Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy n=15 psoriatic plaques Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Percentage Change in Psoriatic Plaque Area after session 6	101.26 percentage change Standard Deviation 10.81	84.25 percentage change Standard Deviation 21.79	91.96 percentage change Standard Deviation 18.88	82.09 percentage change Standard Deviation 19.15
Percentage Change in Psoriatic Plaque Area after session 12	108.22 percentage change Standard Deviation 24.42	78.89 percentage change Standard Deviation 21.04	84.29 percentage change Standard Deviation 24.33	63.69 percentage change Standard Deviation 21.82

SECONDARY outcome

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

Population: In all the study were 14 participants with 58 total psoriatic plaques divided in 4 groups (14 in C group, 15 in AB group, 14 in PT group, and 15 in BPT group).

The plaques were photographed at a distance of 20 cm with a 12 pixel Lumix digital camera (Panasonic, USA). For color evaluation, the photographs taken before session 1 and after session 12 were analyzed with the Average color seeker software (Version 0.41; IDimager Systems Inc., Scotts Valley, CA, USA), which uses the Red-Green-Blue (RGB) coordinates system that reports the information about the red color channel, associated to erythema occurrence, in arbitrary units. Therefore, greater red color measurements for skin pigmentation may indicate increased erythema. A single value was calculated per psoriatic plaque.

Outcome measures

Outcome measures
Measure	Control Group n=14 psoriatic plaques The control group plaques did not receive any treatment.	Phototherapy Group n=15 psoriatic plaques Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy n=14 psoriatic plaques Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy n=15 psoriatic plaques Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Arbitrary Units Change in Psoriatic Plaque Erythema Before session 1	172.1 arbitrary units Standard Deviation 28.52	150.2 arbitrary units Standard Deviation 24.47	163.9 arbitrary units Standard Deviation 28.13	159.3 arbitrary units Standard Deviation 23.22
Arbitrary Units Change in Psoriatic Plaque Erythema After session 12	179.4 arbitrary units Standard Deviation 19.57	136.5 arbitrary units Standard Deviation 27.50	154.5 arbitrary units Standard Deviation 28.83	157.2 arbitrary units Standard Deviation 30.29

SECONDARY outcome

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

Population: 14 participants

The Psoriasis Area Severity Index (PASI) is an index (score determination) used to express the severity of psoriasis. It combines the severity (erythema, induration and desquamation) and percentage of affected area Instructions For each body section (head, arms, trunk and legs) specify: the percent of area of skin involved the severity of three clinical signs (erythema, induration and desquamation) on a scale from 0 to 4 (from none to maximum). In this study plaque severity was presented as percentage of initial value. A reduction of 75 % on plaque severity was considered effective (Puig, 2007).

Outcome measures

Outcome measures
Measure	Control Group n=14 Participants The control group plaques did not receive any treatment.	Phototherapy Group Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Number of Participants With Change in PASI From Baseline to Session 12 PASI more than 75%	4 Participants	—	—	—
Number of Participants With Change in PASI From Baseline to Session 12 PASI more than 50%	7 Participants	—	—	—
Number of Participants With Change in PASI From Baseline to Session 12 PASI less than 50%	3 Participants	—	—	—

SECONDARY outcome

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

Population: 14 participants

Assessment by Short Form 36 Health Survey (SF-36) score. The SF-36 is a 36-item, patient-reported survey of patient health. The SF-36 is a measure of health status. The SF-36 consists of eight scaled scores, which are the weighted sums of the questions in their section. Each scale is directly transformed into a 0-100 scale on the assumption that each question carries equal weight. The lower the score the more disability. The higher the score the less disability i.e., a score of zero is equivalent to maximum disability and a score of 100 is equivalent to no disability. To calculate the scores it is necessary to purchase special software. Pricing depends on the number of scores that the researcher needs to calculate. The eight sections are: vitality physical functioning bodily pain general health perceptions physical role functioning emotional role functioning social role functioning mental health In this study quality of life were presented as p

Outcome measures

Outcome measures
Measure	Control Group n=14 Participants The control group plaques did not receive any treatment.	Phototherapy Group Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Number of Participants With Change in Quality of Life Increase perception of Quality of life	13 Participants	—	—	—
Number of Participants With Change in Quality of Life Decrease perception of Quality of life	1 Participants	—	—	—

SECONDARY outcome

Timeframe: Session 1 and session 12

Population: 14 participants and 58 total psoriatic plaques divided in the 4 groups

Assessment by Psoriasis Disability Index (PDI) score. The Psoriasis Disability Index is calculated by summing the score of each of the 15 questions, resulting in a maximum of 45 and a minimum of 0. The higher the score, the more quality of life is impaired. The Psoriasis Disability Index can also be expressed as a percentage of the maximum possible score of 45.

Outcome measures

Outcome measures
Measure	Control Group n=14 Participants The control group plaques did not receive any treatment.	Phototherapy Group Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). phototherapy: Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).	Balneotherapy Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	Balneophototherapy Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. balneophototherapy: Twelve sessions of both balneotherapy and phototherapy treatments.
Number of Participants With Change in Psoriasis Disability Maintance of the autoperception of Psoriasis Disability	1 participants	—	—	—
Number of Participants With Change in Psoriasis Disability Improve of the autoperception of Psoriasis Disability	13 participants	—	—	—

Adverse Events

Control Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Phototherapy Group

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balneotherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Balneophototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Professor Gabriel Nasri Marzuca Nassr

UC de Maule

Phone: 56 71 203463

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place