Blue Light in the Treatment of Inflammatory Skin Diseases

NCT06516783 | Completed

• 1 other identifier: UMED-RNN/223/20/KE
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief 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

Conditions

Atopic Dermatitis; Psoriasis Vulgaris; Eczema; Pruritus

Outcome Measures

Primary Outcomes (8)

• 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.

Study Arms (1)

patients with psoriasis, atopic dermatitis, eczema and chronic pruritus

EXPERIMENTAL

The study is scheduled for a maximum of 60 irradiations of blue light (maximum 3 cycles of 20 irradiations each). Phototherapeutic light will be administered for 15 minutes to each side of the body of the patient (30 minutes in total), 3-5 times per week. • Device Full Body Blue GEN 1.0 device (built by PHLECS B.V.) with European Community (EC) Certificate (number 2238613CE01) is used in the study. The device provides phototherapeutic light through light panel with treatment Light Emitting Diodes - LEDs (wavelength 453 nm, irradiance 40mW/cm2; dose 36J for 15min treatment) to one side of the body of the patient who is lying flat on an examination bed

Device: Full Body Blue GEN 1.0 device

Interventions

Full Body Blue GEN 1.0 device DEVICE

Full body blue irradiation in the treatment of inflammatory skin diseases and chronic pruritus

patients with psoriasis, atopic dermatitis, eczema and chronic pruritus

Eligibility Criteria

• Age: 8 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Informed consent to participate in a medical experiment
• Age above 8 years of age
• Diagnosis of psoriasis / eczema / atopic dermatitis
• Chronic pruritus (lasting more than 6 weeks)
• Good general health (no history of other clinically significant diseases according to the doctor's assessment)
• A patient who is able to understand the information related to the experiment, meet the requirements contained in the protocol of the experiment, who undertakes to strictly follow medical recommendations and appear on time for visits.

You may not qualify if:

• Patients with known hypersensitivity to ultraviolet or blue radiation
• Age under 8 years of age
• Women who are pregnant, breastfeeding or planning to become pregnant during the experiment
• Patients unwilling or unable to respect the requirements of the experiment
• Patients with skin diseases other than inflammatory skin diseases or chronic pruritus
• Planned hospitalizations or surgical procedures during the medical experiment
• Patients using medications with proven phototoxic effect
• Diastolic blood pressure\> 95mmHg and \<65mmHg
• Patients with congenital or acquired immune disorders
• Patients with a history or at the time of the examination diagnosed with a malignant skin cancer, severe actinic keratosis or dysplastic moles
• Patients diagnosed with genophotodermatosis, increasing the risk of skin cancers, including xeroderma pigmentosum, Cockayne's syndrome, Bloom's syndrome)
• Patients addicted to alcohol / drugs in the last 12 months

Sponsors & Collaborators

• Medical University of Lodz: lead

Study Sites (1)

Department of Dermatology, Pediatric Dermatology and Dermatological Oncology, Medical University of Lodz

Lodz, Poland

Location

Related Publications (1)

• Sadowska M, Narbutt J, Nolberczak D, Ciazynska M, Skibinska M, Sobolewska-Sztychny D, Aubert D, Lesiak A. Prospective Clinical Study: Full-Body Blue Irradiation in the Treatment of Atopic Dermatitis. Dermatol Ther (Heidelb). 2024 Sep;14(9):2631-2643. doi: 10.1007/s13555-024-01248-3. Epub 2024 Aug 24.

  PMID: 39180711 DERIVED

MeSH Terms

Conditions

Dermatitis, Atopic; Eczema; Pruritus

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous; Hypersensitivity, Immediate; Hypersensitivity; Immune System Diseases; Skin Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Magdalena Sadowska

  Medical University of Lodz

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: June 18, 2024
• First Posted: July 24, 2024
• Study Start: November 27, 2020
• Primary Completion: November 25, 2022
• Study Completion: November 25, 2022
• Last Updated: July 24, 2024

Record last verified: 2024-07

Locations

PL (1)