Evaluation of the Effectiveness and Safety of Blue Light Emitted by LED Lamps Using the PHLECS Device in the Treatment of Inflammatory Skin Diseases
Phase: NA
Conditions: Atopic Dermatitis, Psoriasis Vulgaris, Eczema, Pruritus
Sponsor: Medical University of Lodz

 
 
 
 
 
 
 
 
 
 
THE STUDY PROTOCOL            
date: 2024-07-16 
 
 
PROTOCOL ID: UMED-RNN/223/20/KE 
 
Title: Evaluation of the Effectiveness and Safety of Blue Light Emitted by 
LED Lamps Using the PHLECS Device in the Treatment of Inflammatory 
Skin Diseases 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 
 

THE STUDY PROTOCOL            
date: 2024-07-16 
 
 
ID: UMED-RNN/223/20/KE 
 
Title: Evaluation of the Effectiveness and Safety of Blue Light Emitted by 
LED Lamps Using the PHLECS Device in the Treatment of Inflammatory 
Skin Diseases 
 
 
• The study involves four groups of patients (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., Phlecs, High Tech Campus 
12, 5656 AE Eindhoven, The Netherlands) 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  
• After consent to participate in this study, the observation period will begin and will 
last a maximum of 12 weeks 
 
 
 
1. Day 0 - screening and inclusion, during which the following will be assessed: 
 
- skin examination (including photo documentation), assessing skin phototype according to 
Fitzpatrick’s scale  
- detailed medical history collection 
- quality of life assessment – DLQI 
- Additionally, appropriate scales will be used 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 
 
- an interview will be made regarding comorbidities and the treatment used 
- blood samples collection 
-  Optionally, only in patients who give additional consent a skin biopsy will be taken to evaluate 
the mechanism of action of blue light.  
 
2. visit 1 – first full-body blue irradiation 
  

3. Visit 2 – evaluation of the effectiveness and safety after 10 sessions of blue light 
phototherapy, Blood sample collection 
4. Visit 3 – evaluation of the effectiveness and safety after 20 sessions of blue light 
phototherapy (= after the first cycle of irradiation), Blood sample collection 
5. Visit 4 – evaluation of the effectiveness and safety after 30 sessions of blue light 
phototherapy, Blood sample collection 
6. Visit 5 – evaluation of the effectiveness and safety after 40 sessions of blue light 
phototherapy (= after the second cycle of irradiation), Blood sample collection 
7. Visit 6 – evaluation of the effectiveness and safety after 50 sessions of blue light 
phototherapy, Blood sample collection 
8. 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  
9. 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 
were allowed to use emollients.  
 
Inclusion criteria: 
1. Informed consent to participate in a medical experiment 
2. Age over 8 years of age 
3. Diagnosis of psoriasis / eczema / atopic dermatitis 
4. Chronic pruritus (lasting more than 6 weeks) 
5. Good general health (no history of other clinically significant diseases according to the 
doctor's assessment) 
6. 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: 
1. Patients with known hypersensitivity to ultraviolet or blue radiation 
2. Age under 8 years of age 
3. Women who are pregnant, breastfeeding or planning to become pregnant during the 
experiment 
4. Patients who participated in another experiment / clinical trial within 30 days prior to 
inclusion in the experiment 
5. Patients unwilling or unable to respect the requirements of the experiment 
6. Patients with skin diseases other than inflammatory skin diseases or chronic pruritus 
7. Planned hospitalizations or surgical procedures during the medical experiment 
8. Patients using medications with proven phototoxic effect 
9. Diastolic blood pressure> 95mmHg and <65mmHg 
10. Patients with congenital or acquired immune disorders 

11. Patients with a history or at the time of the examination diagnosed with a malignant skin 
cancer, severe actinic keratosis or dysplastic moles 
12. Patients diagnosed with genophotodermatosis, increasing the risk of skin cancers, including 
xeroderma pigmentosum, Cockayne's syndrome, Bloom's syndrome) 
13. Patients addicted to alcohol / drugs in the last 12 months