Ignite Creation Date:
2024-10-26 @ 3:35 PM
Last Modification Date:
2024-10-26 @ 3:35 PM
Study NCT ID:
NCT06516783
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-06-18
Brief Title:
Blue Light in the Treatment of Inflammatory Skin Diseases
Sponsor:
None
Organization:
None
Study Overview
Official 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
Status:
COMPLETED
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 Fitzpatricks 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 40mWcm2 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
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 40mWcm2 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None