Safety and Effectiveness of Combined LED Light for the Treatment of Mild to Moderate Plaque Type Psoriasis Vulgaris

August 28, 2025 updated by: Steven Baker, Ismart

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Withdrawn

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

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.

Exclusion Criteria:

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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Test

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
Device: Dermawrap - combined 460nm, 633nm and 830nm LED therapy
Daily treatments of 15 minutes of combined LED phototherapy, 5 days per week for 12 weeks.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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)
84 days from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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
A change from baseline of the local psoriasis severity index (LPSI) compared to the control area 28 days after the end of the treatment.
112 days from baseline

Other Outcome Measures

Other Outcome Measures

For clinical trials, a planned measurement described in the protocol that is used to determine the effect of an intervention/treatment on participants. For observational studies, a measurement or observation that is used to describe patterns of diseases or traits, or associations with exposures, risk factors, or treatment. Types of outcome measures include primary outcome measure and secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Safety evaluation; number of adverse incidents, evaluation of pigmentation of skin.
Time Frame: Baseline onwards
Number of adverse incidents including reporting on hyperpigmentation of skin.
Baseline onwards

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ismart

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 1, 2023

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2024

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2024

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 9, 2018

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2018

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 25, 2018

Study Record Updates

Last Update Posted (Estimated)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 4, 2025

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 28, 2025

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • version 2.1 March 24th 2018

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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