Atopic DermatitisNCT06516783
Blue Light in the Treatment of Inflammatory Skin Diseases
A study testing Full Body Blue GEN 1.0 device in people with Atopic Dermatitis and Psoriasis Vulgaris, run by Medical University of Lodz at 1 site in Poland.
Trial 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. Read more about this study
- Who is it for?
- Ages 8 years and olderHealthy volunteers can take part
- Conditions the study is for
- Atopic Dermatitis, Psoriasis Vulgaris, Eczema
- What is being tested?
- Full Body Blue GEN 1.0 device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 41 participants
- Where
- 1 sitePoland
- Study dates
- 27 Nov 2020to 25 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 years and older
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Dermatology, Pediatric Dermatology and Dermatological Oncology, Medical University of Lodz
Lodz
About this study
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
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:
Read more
- 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
Read the 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
- Being tested
- Full Body Blue GEN 1.0 device
- Medical subject headings
- Dermatitis, Atopic, Eczema, Pruritus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Full Body Blue GEN 1.0 deviceDevice
Full body blue irradiation in the treatment of inflammatory skin diseases and chronic pruritus
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Device: Full Body Blue GEN 1.0 device |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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
Measured: 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.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jul 2024
- Study start27 Nov 2020
- Primary completion25 Nov 2022
- Study completion25 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Atopic DermatitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 41 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University of Lodz
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Magdalena Sadowska, Medical University of Lodz
- Investigators
- Magdalena Sadowska, Principal investigator, Medical University of Lodz
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06516783
- Sponsor's protocol ID
- UMED-RNN/223/20/KE
- Status last verified
- Jul 2024
- First submitted
- 18 Jun 2024
- Last updated
- 24 Jul 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 39180711
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06516783
- Acronym / sponsor ID
- UMED-RNN/223/20/KE
- Conditions
- Atopic Dermatitis, Psoriasis Vulgaris, Eczema, Pruritus
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 41 participants (actual)
- Lead sponsor
- Medical University of LodzUniversity, hospital or other
- Study start
- 27 Nov 2020 (actual)
- Primary completion
- 25 Nov 2022 (actual)
- Study completion
- 25 Nov 2022 (actual)
- First posted
- 24 Jul 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients with psoriasis, atopic dermatitis, eczema and chronic pruritus | Experimental | Device: Full Body Blue GEN 1.0 deviceThe 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 |
Who may qualify
- Ages
- 8 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (6 listed)
- 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)
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Full Body Blue GEN 1.0 deviceFull body blue irradiation in the treatment of inflammatory skin diseases and chronic pruritus | Device | patients with psoriasis, atopic dermatitis, eczema and chronic pruritus |
Primary outcome
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 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 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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2024.
- Derived from this study: PubMed 39180711Sadowska 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Magdalena Sadowska principal investigator
Medical University of Lodz
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Full Body Blue GEN 1.0 device in people with Atopic Dermatitis and Psoriasis Vulgaris, run by Medical University of Lodz at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Jul 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06516783, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2024.