Evaluation of the Effectiveness and Safety of Blue Light Emitted by LED Lamps Using the PHLECS Device in the Treatment of Inflammatory Skin Diseases
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Medical University of Lodz
- Enrollment
- 41
- Locations
- 1
- Primary Endpoint
- Statistically significant change in VAS (Visual Analogue Scale) score of the patients after blue light irradiation
Study Overview
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
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 8 Years to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
Exclusion Criteria
- •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 who participated in another experiment / clinical trial within 30 days prior to inclusion in 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
Arms & Interventions
patients with psoriasis, atopic dermatitis, eczema and chronic pruritus
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
Intervention: Full Body Blue GEN 1.0 device (Device)
Outcomes
Primary Outcomes
Statistically significant change in VAS (Visual Analogue Scale) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in PASI (Psoriasis Area Severity Index) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in PGA (Physician's Global Assessment) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in 10-item Pruritus Severity Scale score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in IGA (Investigators' Global Assessment) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in SCORAD (SCORing Atopic Dermatitis) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant change in EASI (Eczema Area Severity Index) score of the patients after blue light irradiation
Time Frame: 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 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
Statistically significant (p <0.05) change in DLQI (Dermatology Life Quality Index)
Time Frame: 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; 0-30 points; higher scores mean a worse outcome) after blue light irradiations in patients with psoriasis vulgaris, atopic dermatitis, eczema, chronic pruritus
Secondary Outcomes
No secondary outcomes reported
Investigators
Magdalena Sadowska
MD
Medical University of Lodz