NCT06516783

Blue Light in the Treatment of Inflammatory Skin Diseases

Evaluation of the Effectiveness and Safety of Blue Light Emitted by LED Lamps Using the PHLECS Device in the Treatment of Inflammatory Skin Diseases

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: Medical University of Lodz · Academic / Other
• Sex: All
• Age: 8 Years
• Healthy volunteers: Accepted

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

Detailed description

After giving written, informed consent, skin examination will be performed (including photo documentation) and each patient will have skin phototype assessed according to Fitzpatrick's scale. A detailed medical history will be collected. In addition, patients will complete the Dermatology Life Quality Index (DLQI) questionnaire and 10-item pruritus severity scale. Clinical assessment will be performed depending on the disease: PASI, PGA, VAS, 10-item Pruritus Severity Scale - psoriasis vulgaris; IGA, VAS, 10-item Pruritus Severity Scale - eczema; SCORAD, EASI, VAS, 10-item Pruritus Severity Scale - atopic dermatitis; VAS, 10-item Pruritus Severity Scale - chronic pruritus. On day 0, before the start of the treatment blood samples will be collected. Optionally, with additional consent, a skin biopsy will be taken. The study is scheduled for a maximum of 60 irradiations of blue light (maximum 3 cycles of 20 irradiations each). Phototherapeutic light (wavelength 453 nm, irradiance 40mW/cm2; dose 36J for 15min treatment) will be administered for 15 minutes to each side of the body of the patient (30 minutes in total), 3-5 times per week using the PHLECS Full Body Blue device (with European Community Certificate number 2238613CE01). Visits schedule: Visit 1 - First irradiation; Visit 2 - evaluation of the effectiveness and safety after 10 sessions of blue light phototherapy, blood sample collection; Visit 3 - evaluation of the effectiveness and safety after 20 sessions of blue light phototherapy (= after the first cycle of irradiation), Blood sample collection; Visit 4 - evaluation of the effectiveness and safety after 30 sessions of blue light phototherapy, Blood sample collection; Visit 5 - evaluation of the effectiveness and safety after 40 sessions of blue light phototherapy (= after the second cycle of irradiation), Blood sample collection; Visit 6 - evaluation of the effectiveness and safety after 50 sessions of blue light phototherapy, Blood sample collection; Visit 7 - end of treatment visit - after 60 sessions of blue light phototherapy (= after the third radiation cycle), during which we will re-evaluate the condition of the skin, quality of life, safety of the device used and blood samples will be taken. Optionally, with additional consent, a skin biopsy will be taken. If, for any reason, the study is terminated earlier or if the skin lesions have completely disappeared before 60 irradiations - the end of treatment visit will take place earlier; Visit 8 - assessment of the clinical condition 4 weeks after the cessation of therapy. During blue light therapy, follow-up visits will be performed to assess the safety and effectiveness of the device. At the last control visit (end of treatment visit) the same parameters will be assessed as during the first one. In the case of remission of skin lesions earlier than envisaged in the study protocol, the end of treatment visit will take place earlier. Photographic documentation will be carried out at each visit. During the treatment patients will be allowed to use emollients. Statistical analysis will be performed.

Conditions

• Atopic Dermatitis
• Psoriasis Vulgaris
• Eczema
• Pruritus

Interventions

Type	Name	Description
DEVICE	Full Body Blue GEN 1.0 device	Full body blue irradiation in the treatment of inflammatory skin diseases and chronic pruritus

Timeline

• Start date: 2020-11-27
• Primary completion: 2022-11-25
• Completion: 2022-11-25
• First posted: 2024-07-24
• Last updated: 2024-07-24

Locations

1 site across 1 country: Poland