Psoriasis VulgarisNCT03507946
Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris
A study testing Dermawrap - combined 460nm, 633nm and 830nm LED therapy in people with Psoriasis Vulgaris, run by Ismart.
Trial summary
The purpose of this study is to investigate whether light therapy can help improve plaque psoriasis. This is a study based on a new medical device. The device produces its light from light emitting diodes. This type of technology has been used for several years in the treatment of other skin conditions. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Dermawrap - combined 460nm, 633nm and 830nm LED therapy
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2023to Jun 2024
- 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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male \& females; 18 to 65 years of age with mild to moderate psoriasis ≤10 PASI according to the Psoriasis Area Severity Index.
- Plaques comparable in terms of size, duration and severity and where possible on comparable body areas according to the localized psoriasis severity index (LPSI).
- Fitzpatrick, I-V photo type skin types. Written informed consent is given. Volunteers agree NOT to use any over the counter or prescriptive psoriasis treatments during the study period unless specifically advised by the research staff.
Who cannot join
- Volunteers who suffer from Erythrodermic, exfoliative or pustular psoriasis. Volunteers who suffer from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema or Albinism.
- Volunteers who suffer from genetic deficiencies that increase susceptibility to dermatologic cancer such as Xeroderma pigmentosum.
- Volunteers who suffer from diffuse actinic damage of the skin. Volunteers who suffer from localised fungal or bacterial skin infections in or around the treatment area.
- Volunteers currently taking (or a history of taking) medication listed in Photosensitive drug list in instructions for use.
- Subjects who have any known allergies to the ingredients in the emollient used in the study.
- Volunteers with known malignancy and or undergoing chemotherapy, radiotherapy or high doses of corticosteroids.
Show all 10Show fewer
- Volunteer suffers from keloid scars, or birthmarks in the treatment area. Females who are pregnant, breastfeeding or who wish to become pregnant during the study period.
- Enrolled in another clinical trial during the same study period. The volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial and which may interfere with the course or outcome of the study.
- The volunteer has a medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g. alcoholism or drug abuse).
- A volunteer is undergoing or is likely to undergo other treatments.
About this study
Official title: Single Center, Randomized, Blinded, Controlled Trial Evaluating the Safety and Effectiveness of Combined 460nm, 633nm and 830nm LED Light for the Treatment of Mild to Moderate Plaque-Type Psoriasis Vulgaris
The purpose of this study is to investigate whether light therapy can help improve plaque psoriasis. This is a study based on a new medical device. The device produces its light from light emitting diodes. This type of technology has been used for several years in the treatment of other skin conditions. However, the investigators want to study the effect of a combination of very specific wavelengths of light on reducing the signs and symptoms of plaque psoriasis.
The Investigators are looking to recruit 25 volunteers from the general population between the ages of 18 and 65 years old with mild to moderate plaque psoriasis and who are otherwise healthy. The light treatments are 5 times a week for 12 weeks and the treatment is self-administered at home. Each treatment is 15 minutes. The total duration of the study is 16 weeks.
This is a controlled trial. This means that the volunteer will treat one plaque with the light therapy device and the other plaque will remain untreated for the period of the study.
Read the detailed description
This is a single center, randomized, blinded, interindividual, study involving 25 healthy subjects. After informed consent, confidentiality and photographic release forms, volunteers who meet all inclusion criteria and none of the exclusion criteria on page 4, will be entered into the study. Subjects with a PASI of ≤10 will be included in the study.
At Baseline, the Principle Investigator will identify comparable study plaques (where possible the plaques should be of comparable size, duration and severity and where possible on comparable body areas).
The plaques will be evaluated using the Localised Psoriasis Severity Index (LPSI).
At this point and thereafter, the Principle Investigator will be blinded to the intervention/plaque.
The plaques will be numbered 1 and 2 by the study coordinator. The plaques will then be randomised by the study coordinator to receive either the active treatment or act as the control.
Subjects test and control plaque will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis.
After randomization subjects will be instructed on how to use the Dermawrap device and the treatment schedule (5 x weekly treatments for 12 weeks).
A topical emollient (Hydrogel) will be dispensed to the subject and the subject will be instructed on its use and frequency (2 x weekly treatments for 12 weeks).
The Subjects were then be asked to carry out a self-treatment in front of the study staff. Subjects will be instructed on potential side effects and severity and encouraged to contact the research center in relation to any side effects or concerns.
Subjects will be given a subject diary to complete daily to capture any adverse incidents and record their treatment and treatment experiences.
Seven (7) (+/- 7days) after Baseline, subjects will be contacted by study staff to check for any adverse incidents or problems in using the device. Subjects will be asked if there has been any change in their health or medication from their last visit.
Twenty-eight (28) days (+/- 7days) after Baseline subjects will return to the study center. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents.
Subjects test and control plaque will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka). Subjects test and control plaque will be photographed.
The device will be checked, and usage data will be collected from the device. The topical emollient (Hydrogel) will be dispensed to the subject.
Fifty-six (56) days (+/- 7days) after baseline subjects return to the study center for assessment. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents The device will be checked, and usage data will be collected from the device. Subjects test and control plaque will be evaluated using the Localised Psoriasis Severity Index (LPSI) by the Blinded PI and will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects test and control plaque will be photographed Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis. The topical emollient (Hydrogel) will be dispensed to the subject.
Eighty-four (84) days (+/- 7days) after baseline subjects return to the study center for assessment. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded.
Subjects diary will be collected and reviewed by the study staff for any adverse incidents The device will be collected from the subject, will be checked, and usage data will be collected from the device. The device will not be returned to the subject.
Subjects test and control plaque will be evaluated using the Localised Psoriasis Severity Index (LPSI) by the Blinded PI and will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects test and control plaque will be photographed Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis. In addition, the subject will be asked to complete a standardized system usability scale (SUS). At day 84 (+/- 7 days) the subject will stop treatment.
One hundred and twelve (112) days (+/- 7days) the subject will return to the study center. Subjects will be asked by the Research assistant or Study coordinator if they have experienced any changes in their health or taken new/adjusted current medications since the last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents.
Blinded physician (PI) assessment of psoriasis plaques using the Localised Psoriasis Severity Index (LPSI), mechanical evaluation of hyperpigmentation and erythema using MC1000® (Courage and Khazaka).
Standardised digital photography and Subject self-assessment of treatment response Including Dermatology Life Quality Index (DLQI) will be conducted. Unless any AE or SAE have been reported and ongoing the subject will be signed out of the study.
The duration of subject participation is 16 weeks. The total duration of the study is expected to be 12 months to include recruitment of subjects.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Dermawrap - combined 460nm, 633nm and 830nm LED therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermawrap - combined 460nm, 633nm and 830nm LED therapyDevice
Daily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.
| Study group | Role | What they receive |
|---|---|---|
| Test | Experimental | Subject self control; Plaque 1: Dermawrap - combined 460nm, 633nm, and 830nm LED therapyDaily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.
Plaque 2: No Intervention Receives: Device: Dermawrap - combined 460nm, 633nm and 830nm LED therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment
A change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment period (84 days)
Measured: 84 days from baseline
Secondary outcomes (1)
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of study period
A change from baseline of the local psoriasis severity index (LPSI) compared to the control area 28 days after the end of the treatment.
Measured: 112 days from baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2018
- Study startJan 2023 (estimated)
- Primary completionJan 2024 (estimated)
- Study completionJun 2024 (estimated)
Why it stopped: Lack of funding and sponsor decided to not pursue clinical trial
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies 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
- Model description
- Randomized, Blinded, Controlled Trial
- Masking
- None (open label)
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ismart
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Principal investigator, Steven Baker, Ismart
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03507946
- Sponsor's protocol ID
- version 2.1 March 24th 2018
- Status last verified
- Aug 2025
- First submitted
- 9 Apr 2018
- Last updated
- 4 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Single Center, Randomized, Blinded, Controlled Trial Evaluating the Safety and Effectiveness of Combined 460nm, 633nm and 830nm LED Light for the Treatment of Mild to Moderate Plaque-Type Psoriasis Vulgaris
- ClinicalTrials.gov ID
- NCT03507946
- Acronym / sponsor ID
- version 2.1 March 24th 2018
- Conditions
- Psoriasis Vulgaris
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Lack of funding and sponsor decided to not pursue clinical trial
- Enrolment
- 0 participants (actual)
- Lead sponsor
- IsmartIndustry (pharma, biotech, devices)
- Study start
- Jan 2023 (estimated)
- Primary completion
- Jan 2024 (estimated)
- Study completion
- Jun 2024 (estimated)
- First posted
- 25 Apr 2018 (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 purpose of this study is to investigate whether light therapy can help improve plaque psoriasis. This is a study based on a new medical device. The device produces its light from light emitting diodes. This type of technology has been used for several years in the treatment of other skin conditions. However, the investigators want to study the effect of a combination of very specific wavelengths of light on reducing the signs and symptoms of plaque psoriasis.
The Investigators are looking to recruit 25 volunteers from the general population between the ages of 18 and 65 years old with mild to moderate plaque psoriasis and who are otherwise healthy. The light treatments are 5 times a week for 12 weeks and the treatment is self-administered at home. Each treatment is 15 minutes. The total duration of the study is 16 weeks.
This is a controlled trial. This means that the volunteer will treat one plaque with the light therapy device and the other plaque will remain untreated for the period of the study.
Detailed description
This is a single center, randomized, blinded, interindividual, study involving 25 healthy subjects. After informed consent, confidentiality and photographic release forms, volunteers who meet all inclusion criteria and none of the exclusion criteria on page 4, will be entered into the study. Subjects with a PASI of ≤10 will be included in the study.
At Baseline, the Principle Investigator will identify comparable study plaques (where possible the plaques should be of comparable size, duration and severity and where possible on comparable body areas).
The plaques will be evaluated using the Localised Psoriasis Severity Index (LPSI).
At this point and thereafter, the Principle Investigator will be blinded to the intervention/plaque.
The plaques will be numbered 1 and 2 by the study coordinator. The plaques will then be randomised by the study coordinator to receive either the active treatment or act as the control.
Subjects test and control plaque will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis.
After randomization subjects will be instructed on how to use the Dermawrap device and the treatment schedule (5 x weekly treatments for 12 weeks).
A topical emollient (Hydrogel) will be dispensed to the subject and the subject will be instructed on its use and frequency (2 x weekly treatments for 12 weeks).
The Subjects were then be asked to carry out a self-treatment in front of the study staff. Subjects will be instructed on potential side effects and severity and encouraged to contact the research center in relation to any side effects or concerns.
Subjects will be given a subject diary to complete daily to capture any adverse incidents and record their treatment and treatment experiences.
Seven (7) (+/- 7days) after Baseline, subjects will be contacted by study staff to check for any adverse incidents or problems in using the device. Subjects will be asked if there has been any change in their health or medication from their last visit.
Twenty-eight (28) days (+/- 7days) after Baseline subjects will return to the study center. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents.
Subjects test and control plaque will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka). Subjects test and control plaque will be photographed.
The device will be checked, and usage data will be collected from the device. The topical emollient (Hydrogel) will be dispensed to the subject.
Fifty-six (56) days (+/- 7days) after baseline subjects return to the study center for assessment. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents The device will be checked, and usage data will be collected from the device. Subjects test and control plaque will be evaluated using the Localised Psoriasis Severity Index (LPSI) by the Blinded PI and will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects test and control plaque will be photographed Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis. The topical emollient (Hydrogel) will be dispensed to the subject.
Eighty-four (84) days (+/- 7days) after baseline subjects return to the study center for assessment. Subjects will be asked if there has been any change in their health or medication from their last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded.
Subjects diary will be collected and reviewed by the study staff for any adverse incidents The device will be collected from the subject, will be checked, and usage data will be collected from the device. The device will not be returned to the subject.
Subjects test and control plaque will be evaluated using the Localised Psoriasis Severity Index (LPSI) by the Blinded PI and will undergo a mechanical evaluation of hyperpigmentation and erythema using a MC1000® (Courage and Khazaka).
Subjects test and control plaque will be photographed Subjects will complete a Dermatology Life Quality Index (DLQI) based on their psoriasis. In addition, the subject will be asked to complete a standardized system usability scale (SUS). At day 84 (+/- 7 days) the subject will stop treatment.
One hundred and twelve (112) days (+/- 7days) the subject will return to the study center. Subjects will be asked by the Research assistant or Study coordinator if they have experienced any changes in their health or taken new/adjusted current medications since the last visit. The PI will be notified of any changes. Any changes will be evaluated by the PI or SC against the exclusion criteria and recorded. Subjects diary will be collected and reviewed by the study staff for any adverse incidents.
Blinded physician (PI) assessment of psoriasis plaques using the Localised Psoriasis Severity Index (LPSI), mechanical evaluation of hyperpigmentation and erythema using MC1000® (Courage and Khazaka).
Standardised digital photography and Subject self-assessment of treatment response Including Dermatology Life Quality Index (DLQI) will be conducted. Unless any AE or SAE have been reported and ongoing the subject will be signed out of the study.
The duration of subject participation is 16 weeks. The total duration of the study is expected to be 12 months to include recruitment of subjects.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Randomized, Blinded, Controlled Trial
| Arm | Type | Receives |
|---|---|---|
| Test | Experimental | Device: Dermawrap - combined 460nm, 633nm and 830nm LED therapySubject self control; Plaque 1: Dermawrap - combined 460nm, 633nm, and 830nm LED therapyDaily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks. Plaque 2: No Intervention |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Healthy male \& females; 18 to 65 years of age with mild to moderate psoriasis ≤10 PASI according to the Psoriasis Area Severity Index.
- Plaques comparable in terms of size, duration and severity and where possible on comparable body areas according to the localized psoriasis severity index (LPSI).
- Fitzpatrick, I-V photo type skin types. Written informed consent is given. Volunteers agree NOT to use any over the counter or prescriptive psoriasis treatments during the study period unless specifically advised by the research staff.
Key exclusion criteria (10 listed)
- Volunteers who suffer from Erythrodermic, exfoliative or pustular psoriasis. Volunteers who suffer from a systemic photosensitive disorder such as Lupus erythematosus, photosensitive eczema or Albinism.
- Volunteers who suffer from genetic deficiencies that increase susceptibility to dermatologic cancer such as Xeroderma pigmentosum.
- Volunteers who suffer from diffuse actinic damage of the skin. Volunteers who suffer from localised fungal or bacterial skin infections in or around the treatment area.
- Volunteers currently taking (or a history of taking) medication listed in Photosensitive drug list in instructions for use.
- Subjects who have any known allergies to the ingredients in the emollient used in the study.
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 |
|---|---|---|
| Dermawrap - combined 460nm, 633nm and 830nm LED therapyDaily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks. | Device | Test |
Primary outcome
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment
Time frame: 84 days from baseline
A change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment period (84 days)
1 secondary outcome
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of study period
Time frame: 112 days from baseline
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Sep 2025.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Dermawrap - combined 460nm, 633nm and 830nm LED therapy in people with Psoriasis Vulgaris, run by Ismart.
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 3 inclusion and 10 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: withdrawn, as of the sponsor's last update on 4 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
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 was withdrawn before enrolling participants, so there are no results.
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?
Change from baseline of the local psoriasis severity index (LPSI) compared to the control area at the end of treatment (time frame: 84 days from baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 4 Sep 2025.