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

Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02713711
Enrollment
14
Registered
2016-03-21
Start date
2013-12-31
Completion date
2014-06-30
Last updated
2021-02-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis

Keywords

Psoriasis, balneotherapy, phototherapy, balneophototherapy

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.

Detailed description

On the selected subjects, it was also performed the evaluation of Minimal Erythema Dose (MED) in order to determine an acceptable dose of UV-B light for the type of skin of each patient. Thus, the evaluations were performed according to psoriasis type, area, color and plaques severity. The formula used for the calculation was: MED = 2×t(s)×0,75 t: minimum time for erythema occurrence. Each psoriatic plaque was submitted to three therapeutic sessions per week, during 4 weeks, for a total of 12 sessions. For the application of AB, the AB group plaques were immersed during 15 minutes in a 35 or 75 l hydrotherapy whirlpool (TB-T45 model and TB-T90 model respectively, Enraf Nonius Company SA, Spain) filled with a solution of warm water (32 °C) and natural sea salt (250 g/L), following the similar protocol of others authors always ensuring that the plaques not receiving this treatment were kept isolated with flexible and insulating adhesive patches (Nexcare® Factory 3M, Chile). For the implementation of PT, the PT group plaques that would not receive radiation were covered with thick cloth towels, while the healthy skin surrounding the treated plaques were coated with liquid petroleum jelly. Both patients and attendant were protected with special lenses with filter against UV light (Oakley Jupiter, USA). UV-B radiation was applied with the UV Endolamp 474 device (Enraf Nonius Company SA, Spain), 60 cm away from the plaque and in a perpendicular position. In session 1, the MED was calculated for each subject and used as the time of UV-B exposure. On each further session, the exposure time was increased by 25%, until the limit of 5 minutes. The BPT group plaques received both AB and PT treatments, on the same conditions described above, consecutively. The C group plaques did not receive any treatment. Data Collection 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). 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. The psoriatic plaque severity was assessed before session 1 and one day after session 12 through PASI, which considers erythema, induration and plaque scaling, being 72 points the maximum score. Quality of life assessment was performed using the SF-36 TM v2 health questionnaire, validated for the Chilean population10, and with the psoriasis disability index (PDI), both performed before session 1 and one day after session 12.

Interventions

RADIATIONphototherapy

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

PROCEDUREbalneotherapy

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

PROCEDUREbalneophototherapy

Twelve sessions of both balneotherapy and phototherapy treatments.

Sponsors

Universidad Católica del Maule
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No

Inclusion criteria

* 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).

Exclusion criteria

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

Design outcomes

Primary

MeasureTime frameDescription
Percentage Change in Psoriatic Plaque AreaBefore first session (day 1), after the six session (day 12) and after the twelve session (day 26)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).

Secondary

MeasureTime frameDescription
Arbitrary Units Change in Psoriatic Plaque ErythemaBefore first session (day 1) and after the twelve session (day 26)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.
Number of Participants With Change in PASI From Baseline to Session 12Before first session (day 1) and after the twelve session (day 26)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).
Number of Participants With Change in Quality of LifeBefore first session (day 1) and after the twelve session (day 26)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
Number of Participants With Change in Psoriasis DisabilitySession 1 and session 12Assessment 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.

Participant flow

Participants by arm

ArmCount
All Participants
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.
14
All Participants
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.
58
Total72

Baseline characteristics

CharacteristicAll Participants
Age, Categorical
<=18 years
0 Participants
Age, Categorical
>=65 years
0 Participants
Age, Categorical
Between 18 and 65 years
14 Participants
Age, Continuous37.85 years
STANDARD_DEVIATION 9.85
Region of Enrollment
Chile
14 participants
Sex: Female, Male
Female
7 Participants
Sex: Female, Male
Male
7 Participants

Adverse events

Event typeEG000
affected / at risk
EG001
affected / at risk
EG002
affected / at risk
EG003
affected / at risk
deaths
Total, all-cause mortality
— / —— / —— / —— / —
other
Total, other adverse events
0 / 00 / 00 / 00 / 0
serious
Total, serious adverse events
0 / 00 / 00 / 00 / 0

Outcome results

Primary

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).

Time frame: 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

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupPercentage Change in Psoriatic Plaque Areaafter session 12108.22 percentage changeStandard Deviation 24.42
Control GroupPercentage Change in Psoriatic Plaque Areaafter session 6101.26 percentage changeStandard Deviation 10.81
Phototherapy GroupPercentage Change in Psoriatic Plaque Areaafter session 684.25 percentage changeStandard Deviation 21.79
Phototherapy GroupPercentage Change in Psoriatic Plaque Areaafter session 1278.89 percentage changeStandard Deviation 21.04
BalneotherapyPercentage Change in Psoriatic Plaque Areaafter session 1284.29 percentage changeStandard Deviation 24.33
BalneotherapyPercentage Change in Psoriatic Plaque Areaafter session 691.96 percentage changeStandard Deviation 18.88
BalneophototherapyPercentage Change in Psoriatic Plaque Areaafter session 1263.69 percentage changeStandard Deviation 21.82
BalneophototherapyPercentage Change in Psoriatic Plaque Areaafter session 682.09 percentage changeStandard Deviation 19.15
p-value: 0.3262ANOVA
p-value: 0.01ANOVA
p-value: 0.0646ANOVA
p-value: <0.001ANOVA
p-value: <0.001ANOVA
Secondary

Arbitrary Units Change in Psoriatic Plaque Erythema

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.

Time frame: 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).

ArmMeasureGroupValue (MEAN)Dispersion
Control GroupArbitrary Units Change in Psoriatic Plaque ErythemaBefore session 1172.1 arbitrary unitsStandard Deviation 28.52
Control GroupArbitrary Units Change in Psoriatic Plaque ErythemaAfter session 12179.4 arbitrary unitsStandard Deviation 19.57
Phototherapy GroupArbitrary Units Change in Psoriatic Plaque ErythemaAfter session 12136.5 arbitrary unitsStandard Deviation 27.5
Phototherapy GroupArbitrary Units Change in Psoriatic Plaque ErythemaBefore session 1150.2 arbitrary unitsStandard Deviation 24.47
BalneotherapyArbitrary Units Change in Psoriatic Plaque ErythemaBefore session 1163.9 arbitrary unitsStandard Deviation 28.13
BalneotherapyArbitrary Units Change in Psoriatic Plaque ErythemaAfter session 12154.5 arbitrary unitsStandard Deviation 28.83
BalneophototherapyArbitrary Units Change in Psoriatic Plaque ErythemaBefore session 1159.3 arbitrary unitsStandard Deviation 23.22
BalneophototherapyArbitrary Units Change in Psoriatic Plaque ErythemaAfter session 12157.2 arbitrary unitsStandard Deviation 30.29
p-value: 0.208t-test, 2 sided
p-value: 0.0136t-test, 2 sided
p-value: 0.2987t-test, 2 sided
p-value: 0.8347t-test, 2 sided
p-value: 0.0001ANOVA
Secondary

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

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).

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

Population: 14 participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control GroupNumber of Participants With Change in PASI From Baseline to Session 12PASI more than 75%4 Participants
Control GroupNumber of Participants With Change in PASI From Baseline to Session 12PASI more than 50%7 Participants
Control GroupNumber of Participants With Change in PASI From Baseline to Session 12PASI less than 50%3 Participants
Secondary

Number of Participants With Change in Psoriasis Disability

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.

Time frame: Session 1 and session 12

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

ArmMeasureGroupValue (NUMBER)
Control GroupNumber of Participants With Change in Psoriasis DisabilityImprove of the autoperception of Psoriasis Disability13 participants
Control GroupNumber of Participants With Change in Psoriasis DisabilityMaintance of the autoperception of Psoriasis Disability1 participants
Secondary

Number of Participants With Change in Quality of Life

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

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

Population: 14 participants

ArmMeasureCategoryValue (COUNT_OF_PARTICIPANTS)
Control GroupNumber of Participants With Change in Quality of LifeIncrease perception of Quality of life13 Participants
Control GroupNumber of Participants With Change in Quality of LifeDecrease perception of Quality of life1 Participants

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026