Clinical Trial Details
— Status: Not yet recruiting
Administrative data
| NCT number |
NCT03507946 |
| Other study ID # |
version 2.1 March 24th 2018 |
| Secondary ID |
|
| Status |
Not yet recruiting |
| Phase |
N/A
|
| First received |
|
| Last updated |
|
| Start date |
January 2023 |
| Est. completion date |
June 2024 |
Study information
| Verified date |
August 2022 |
| Source |
Ismart |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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. 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.
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.
