Blue Light in the Treatment of Inflammatory Skin Diseases
NCT Number: NCT06516783
Status: COMPLETED
Study Type: INTERVENTIONAL
Phases: NA
Conditions: Atopic Dermatitis|Psoriasis Vulgaris|Eczema|Pruritus
Interventions: DEVICE: Full Body Blue GEN 1.0 device
Sponsor: Medical University of Lodz
Sex: ALL
Age: CHILD, ADULT, OLDER_ADULT
Enrollment: 41
Study Design: Allocation: NA|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2020-11-27
Completion Date: 2022-11-25
Locations: Department of Dermatology, Pediatric Dermatology and Dermatological Oncology, Medical University of Lodz, Lodz, Poland

Summary:
The goal of this clinical trial is to assess the effectiveness of full-body blue light irradiations in the treatment of inflammatory skin diseases (atopic dermatitis, psoriasis, eczema) and chronic pruritus in adult and pediatric populations.

The main questions it aims to answer are:

* If blue light irradiations have an impact on the improvement in skin condition
* If blue light irradiations affect the patients' quality of life
* If blue light irradiations decrease pruritus

Participants will:

* Be administered phototherapeutic blue light (453 nm) for 15 minutes to each side of the body (30 minutes in total), 3-5 times per week. The study is scheduled for a maximum of 60 irradiations of blue light.
* Complete the Dermatology Life Quality Index questionnaire and a 10-item pruritus severity scale
* Be assessed using dermatologic scales
* Have blood samples collected

Primary Outcome Measures: Statistically significant change in PASI (Psoriasis Area Severity Index) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiations using:

PASI - Psoriasis Area Severity Index (0-72 points; higher scores mean a worse outcome) in patients with psoriasis vulgaris, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in PGA (Physician's Global Assessment) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

PGA - Physician's Global Assessment (0-5 points; higher scores mean a worse outcome) in patients with psoriasis vulgaris, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in VAS (Visual Analogue Scale) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

VAS - Visual Analogue Scale (0-10 points; higher scores mean a worse outcome) in patients with psoriasis vulgaris, atopic dermatitis, eczema and chronic pruritus, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in 10-item Pruritus Severity Scale score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

10-item Pruritus Severity Scale (3-20 points; higher scores mean a worse outcome) in patients with psoriasis vulgaris, atopic dermatitis, eczema and chronic pruritus, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in IGA (Investigators' Global Assessment) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

IGA - Investigators' Global Assessment (0-5 points; higher scores mean a worse outcome) in patients with eczema, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in SCORAD (SCORing Atopic Dermatitis) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

SCORAD - SCORing Atopic Dermatitis (0-103 points; higher scores mean a worse outcome) in patients with atopic dermatitis, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant change in EASI (Eczema Area Severity Index) score of the patients after blue light irradiation, Statistically significant (p \<0.05) change in skin condition of the patients after blue light irradiation using:

EASI - Eczema Area Severity Index (0-72 points; higher scores mean a worse outcome) in patients with atopic dermatitis, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.|Statistically significant (p <0.05) change in DLQI (Dermatology Life Quality Index), Statistically significant (p \<0.05) change in DLQI (Dermatology Life Quality Index; 0-30 points; higher scores mean a worse outcome) after blue light irradiations in patients with psoriasis vulgaris, atopic dermatitis, eczema, chronic pruritus, From the date of the first irradiation (visit 1) until the cessation of therapy, up to 25 weeks. In case of earlier cessation of therapy, the evaluation will be conducted at the last visit and then 4 weeks after the cessation of therapy.