PsoriasisNCT02713711
Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis
A study testing phototherapy, balneotherapy and balneophototherapy in people with Psoriasis, run by Universidad Católica del Maule.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Psoriasis
- What is being tested?
- phototherapy, balneotherapy and balneophototherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 14 participants
- Where
- No sites listed yet
- Study dates
- Dec 2013to Jun 2014
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- pregnancy,
- skin carcinoma,
- severe diabetes mellitus,
- uncontrolled chronic pathologies and/or severe cardiac/renal insufficiency and/or acute infections.
About this study
Official title: Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial
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.
Read the 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.
- Conditions
- Psoriasis
- Being tested
- phototherapy, balneotherapy, balneophototherapy
- Keywords
- Psoriasis, balneotherapy, phototherapy, balneophototherapy
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
phototherapyRadiation
Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).
balneotherapyProcedure or surgery
Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).
balneophototherapyProcedure or surgery
Twelve sessions of both balneotherapy and phototherapy treatments.
| Study group | Role | What they receive |
|---|---|---|
| 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). Receives: 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. Receives: Procedure: balneotherapy |
| balneophototherapy | Experimental | Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. Receives: Procedure: balneophototherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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
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.
Measured: Before first session (day 1) and after the twelve session (day 26)
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).
Measured: Before first session (day 1) and after the twelve session (day 26)
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
Measured: Before first session (day 1) and after the twelve session (day 26)
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.
Measured: Session 1 and session 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2016 (estimated)
- Study startDec 2013
- Primary completionJun 2014
- Study completionJun 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for PsoriasisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 14 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universidad Católica del Maule
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gabriel Nasri Marzuca Nassr, Universidad Católica del Maule
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02713711
- Sponsor's protocol ID
- TUCM/1261/N822c/2014
- Other IDs
- 11/2012
- Status last verified
- Jan 2021
- First submitted
- 10 Mar 2016
- Last updated
- 15 Feb 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial
- ClinicalTrials.gov ID
- NCT02713711
- Acronym / sponsor ID
- TUCM/1261/N822c/2014
- Conditions
- Psoriasis
- Keywords
- Psoriasis, balneotherapy, phototherapy, balneophototherapy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 14 participants (actual)
- Lead sponsor
- Universidad Católica del MauleUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Jun 2014 (actual)
- Study completion
- Jun 2014 (actual)
- First posted
- 21 Mar 2016 (estimated)
- Results
- Posted 15 Feb 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| control group | No intervention | –The control group plaques did not receive any treatment. |
| phototherapy group | Experimental | Radiation: phototherapyTwelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED). |
| balneotherapy | Experimental | Procedure: balneotherapyTwelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques. |
| balneophototherapy | Experimental | Procedure: balneophototherapyTwelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- 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).
Key exclusion criteria (4 listed)
- pregnancy,
- skin carcinoma,
- severe diabetes mellitus,
- uncontrolled chronic pathologies and/or severe cardiac/renal insufficiency and/or acute infections.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| phototherapyTwelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED). | Radiation | phototherapy group |
| balneotherapyTwelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L). | Procedure or surgery | balneotherapy |
| balneophototherapyTwelve sessions of both balneotherapy and phototherapy treatments. | Procedure or surgery | balneophototherapy |
Primary outcome
Percentage Change in Psoriatic Plaque Area
Time frame: Before 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).
4 secondary outcomes
Arbitrary Units Change in Psoriatic Plaque Erythema
Time frame: Before first session (day 1) and after the twelve session (day 26)
Number of Participants With Change in PASI From Baseline to Session 12
Time frame: Before first session (day 1) and after the twelve session (day 26)
Number of Participants With Change in Quality of Life
Time frame: Before first session (day 1) and after the twelve session (day 26)
Number of Participants With Change in Psoriasis Disability
Time frame: Session 1 and session 12
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Feb 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing phototherapy, balneotherapy and balneophototherapy in people with Psoriasis, run by Universidad Católica del Maule.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Feb 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Change in Psoriatic Plaque Area (time frame: Before first session (day 1), after the six session (day 12) and after the twelve session (day 26)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Feb 2021.