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

Primary Purpose

Psoriasis

Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
phototherapy
balneotherapy
balneophototherapy
Sponsored by
Universidad Católica del Maule
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, balneotherapy, phototherapy, balneophototherapy

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm Type

    No Intervention

    Experimental

    Experimental

    Experimental

    Arm Label

    control group

    phototherapy group

    balneotherapy

    balneophototherapy

    Arm Description

    The control group plaques did not receive any treatment.

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

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

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

    Outcomes

    Primary Outcome Measures

    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).

    Secondary Outcome Measures

    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.
    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).
    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
    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.

    Full Information

    First Posted
    March 10, 2016
    Last Updated
    January 25, 2021
    Sponsor
    Universidad Católica del Maule
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02713711
    Brief Title
    Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis
    Official Title
    Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    January 2021
    Overall Recruitment Status
    Completed
    Study Start Date
    December 2013 (undefined)
    Primary Completion Date
    June 2014 (Actual)
    Study Completion Date
    June 2014 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Principal Investigator
    Name of the Sponsor
    Universidad Católica del Maule

    4. Oversight

    Data Monitoring Committee
    Yes

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Psoriasis
    Keywords
    Psoriasis, balneotherapy, phototherapy, balneophototherapy

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Randomized
    Enrollment
    14 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    control group
    Arm Type
    No Intervention
    Arm Description
    The control group plaques did not receive any treatment.
    Arm Title
    phototherapy group
    Arm Type
    Experimental
    Arm Description
    Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).
    Arm Title
    balneotherapy
    Arm Type
    Experimental
    Arm Description
    Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.
    Arm Title
    balneophototherapy
    Arm Type
    Experimental
    Arm Description
    Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.
    Intervention Type
    Radiation
    Intervention Name(s)
    phototherapy
    Intervention Description
    Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).
    Intervention Type
    Procedure
    Intervention Name(s)
    balneotherapy
    Intervention Description
    Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).
    Intervention Type
    Procedure
    Intervention Name(s)
    balneophototherapy
    Intervention Description
    Twelve sessions of both balneotherapy and phototherapy treatments.
    Primary Outcome Measure Information:
    Title
    Percentage Change in Psoriatic Plaque Area
    Description
    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)
    Secondary Outcome Measure Information:
    Title
    Arbitrary Units Change in Psoriatic Plaque Erythema
    Description
    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)
    Title
    Number of Participants With Change in PASI From Baseline to Session 12
    Description
    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)
    Title
    Number of Participants With Change in Quality of Life
    Description
    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)
    Title
    Number of Participants With Change in Psoriasis Disability
    Description
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    55 Years
    Accepts Healthy Volunteers
    No
    Eligibility Criteria
    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.

    12. IPD Sharing Statement

    Plan to Share IPD
    No

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