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

• Sponsor: Universidad Católica del Maule (Other)
• Overall Status: Completed
• CT.gov ID: NCT02713711
• Collaborator: (none)
• Enrollment: 14
• Arms: 4
• Duration (Months): 6

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis	Radiation: phototherapy; Procedure: balneotherapy; Procedure: balneophototherapy	N/A

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

• Study Type: Interventional
• Actual Enrollment: 14 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Comparison of the Effectiveness of Artificial Balneotherapy, Phototherapy and Artificial Balneophototherapy in the Treatment of Psoriasis: A Randomized, Controlled Trial
• Study Start Date: Dec 1, 2013
• Actual Primary Completion Date: Jun 1, 2014
• Actual Study Completion Date: Jun 1, 2014

Arms and Interventions

Arm	Intervention/Treatment
No Intervention: control group The control group plaques did not receive any treatment.
Experimental: phototherapy group Twelve sessions of phototherapy (UV-B) applied on psoriatic plaques according to individual initial evaluation of Minimal Erythema Dose (MED).	Radiation: phototherapy; Twelve sessions of phototherapy (UV-B) according to individual initial evaluation of Minimal Erythema Dose (MED).
Experimental: balneotherapy Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L) applied on psoriatic plaques.	Procedure: balneotherapy; Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).
Experimental: balneophototherapy Twelve sessions of both balneotherapy and phototherapy treatments on the same conditions described above applied on psoriatic plaques.	Procedure: balneophototherapy; Twelve sessions of both balneotherapy and phototherapy treatments.

Outcome Measures

Primary Outcome Measures

1. Percentage Change in Psoriatic Plaque Area [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).

Secondary Outcome Measures

1. Arbitrary Units Change in Psoriatic Plaque Erythema [Before 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.

2. Number of Participants With Change in PASI From Baseline to Session 12 [Before 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).

3. Number of Participants With Change in Quality of Life [Before 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

4. Number of Participants With Change in Psoriasis Disability [Session 1 and session 12]

   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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 55 Years
• Sexes Eligible for Study: All
• Accepts 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.

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Universidad Católica del Maule

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Gabriel Nasri Marzuca Nassr, PT; MSc, Universidad Católica del Maule
• ClinicalTrials.gov Identifier: NCT02713711
• Other Study ID Numbers: TUCM/1261/N822c/2014; 11/2012
• First Posted: Mar 21, 2016
• Last Update Posted: Feb 15, 2021
• Last Verified: Jan 1, 2021

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Keywords provided by Gabriel Nasri Marzuca Nassr, PT; MSc, Universidad Católica del Maule: Psoriasis; balneotherapy; phototherapy; balneophototherapy
• Additional relevant MeSH terms: Psoriasis

Study Results

Participant Flow

Arm/Group Title	Control Group	Phototherapy Group	Balneotherapy	Balneophototherapy
Arm/Group 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). phototherapy: Twelve sessions of phototherapy (UV-B) 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. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	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.
Period Title: Overall Study
STARTED	9	6	6	10
COMPLETED	9	6	6	10
NOT COMPLETED	0	0	0	0

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Each participant had psoriatic plaques divided into 4 groups. 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). - phototherapy: Twelve sessions of phototherapy (UV-B) 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. - balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L). 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 Participants	14
Overall psoriatic plaques	58
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	14 100%
>=65 years	0 0%
Age (years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [years]	37.85 (9.85)
Sex: Female, Male (Count of Participants)
Female	7 50%
Male	7 50%
Region of Enrollment (participants) [Number]
Chile	14 100%

Outcome Measures

1. Primary Outcome

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)

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	Control Group	Phototherapy Group	Balneotherapy	Balneophototherapy
Arm/Group 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). phototherapy: Twelve sessions of phototherapy (UV-B) 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. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	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.
Measure Participants	9	6	6	10
Measure psoriatic plaques	14	15	14	15
after session 12	108.22 (24.42)	78.89 (21.04)	84.29 (24.33)	63.69 (21.82)
after session 6	101.26 (10.81)	84.25 (21.79)	91.96 (18.88)	82.09 (19.15)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments	ANOVA. Sample was calculated with power of 80% and alpha of 0.05.
Statistical Test of Hypothesis	p-Value	0.3262
	Comments
	Method	ANOVA
	Comments	repeated measures ANOVA (Bonferroni post-test) for intragroup analysis

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phototherapy Group
	Comments
	Type of Statistical Test	Superiority
	Comments	ANOVA. Sample was calculated with power of 80% and alpha of 0.05.
Statistical Test of Hypothesis	p-Value	0.01
	Comments
	Method	ANOVA
	Comments	repeated measures ANOVA (Bonferroni post-test) for intragroup analysis

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Balneotherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	ANOVA. Sample was calculated with power of 80% and alpha of 0.05.
Statistical Test of Hypothesis	p-Value	0.0646
	Comments
	Method	ANOVA
	Comments	repeated measures ANOVA (Bonferroni post-test) for intragroup analysis

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Balneophototherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	ANOVA. Sample was calculated with power of 80% and alpha of 0.05.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments	repeated measures ANOVA (Bonferroni post-test) for intragroup analysis

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Control Group, Phototherapy Group, Balneotherapy, Balneophototherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	Two-way ANOVA (Bonferroni post-test) for intergroup analysis.
Statistical Test of Hypothesis	p-Value	<0.001
	Comments
	Method	ANOVA
	Comments

2. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

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).

Arm/Group Title	Control Group	Phototherapy Group	Balneotherapy	Balneophototherapy
Arm/Group 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). phototherapy: Twelve sessions of phototherapy (UV-B) 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. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).	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.
Measure Participants	9	6	6	10
Measure psoriatic plaques	14	15	14	15
Before session 1	172.1 (28.52)	150.2 (24.47)	163.9 (28.13)	159.3 (23.22)
After session 12	179.4 (19.57)	136.5 (27.50)	154.5 (28.83)	157.2 (30.29)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Control Group
	Comments
	Type of Statistical Test	Superiority
	Comments	paired-t test (intragroup analysis)
Statistical Test of Hypothesis	p-Value	0.2080
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 2

Statistical Analysis Overview	Comparison Group Selection	Phototherapy Group
	Comments
	Type of Statistical Test	Superiority
	Comments	paired-t test (intragroup analysis)
Statistical Test of Hypothesis	p-Value	0.0136
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 3

Statistical Analysis Overview	Comparison Group Selection	Balneotherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	paired-t test (intragroup analysis)
Statistical Test of Hypothesis	p-Value	0.2987
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 4

Statistical Analysis Overview	Comparison Group Selection	Balneophototherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	paired-t test (intragroup analysis)
Statistical Test of Hypothesis	p-Value	0.8347
	Comments
	Method	t-test, 2 sided
	Comments

Statistical Analysis 5

Statistical Analysis Overview	Comparison Group Selection	Control Group, Phototherapy Group, Balneotherapy, Balneophototherapy
	Comments
	Type of Statistical Test	Superiority
	Comments	two-way ANOVA with Bonferroni post hoc test (intergroup analysis)
Statistical Test of Hypothesis	p-Value	0.0001
	Comments
	Method	ANOVA
	Comments

3. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

14 participants

Arm/Group Title	All Participants
Arm/Group Description	14 participants with 58 psoriatic plaques divided into 4 groups.
Measure Participants	14
PASI more than 75%	4 28.6%
PASI more than 50%	7 50%
PASI less than 50%	3 21.4%

4. Secondary Outcome

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)

Outcome Measure Data

Analysis Population Description

14 participants

Arm/Group Title	All Participants
Arm/Group Description	14 subjects with 58 psoriatic plaques divided into 4 groups.
Measure Participants	14
Increase perception of Quality of life	13 92.9%
Decrease perception of Quality of life	1 7.1%

5. Secondary Outcome

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

Outcome Measure Data

Analysis Population Description

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

Arm/Group Title	All Participants
Arm/Group Description	Each participant had psoriatic plaques divided into 4 groups. 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). - phototherapy: Twelve sessions of phototherapy (UV-B) 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. - balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L). 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.
Measure Participants	14
Improve of the autoperception of Psoriasis Disability	13 92.9%
Maintance of the autoperception of Psoriasis Disability	1 7.1%

Adverse Events

Time Frame	0 Total Number of Participants at Risk
Adverse Event Reporting Description	Serious and Other [Not Including Serious] Adverse Events were not collected/assessed
Arm/Group Title	Control Group		Phototherapy Group		Balneotherapy		Balneophototherapy
Arm/Group 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). phototherapy: Twelve sessions of phototherapy (UV-B) 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. balneotherapy: Twelve sessions of 15 minutes of balneotherapy (warm water, 32 °C and natural sea salt, 250 g/L).		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.
All Cause Mortality
	Control Group		Phototherapy Group		Balneotherapy		Balneophototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	/ (NaN)		/ (NaN)		/ (NaN)		/ (NaN)
Serious Adverse Events
	Control Group		Phototherapy Group		Balneotherapy		Balneophototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)
Other (Not Including Serious) Adverse Events
	Control Group		Phototherapy Group		Balneotherapy		Balneophototherapy
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/0 (NaN)		0/0 (NaN)		0/0 (NaN)		0/0 (NaN)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.