MedDataX Logo

Blue Light for Treating Psoriasis Vulgaris

NCT ID: NCT02004847

Last Updated: 2015-12-18

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

View full results

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

47 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-09-30

Study Completion Date

2014-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

The purpose of this study is to determine the efficacy and safety of a blue light device for treating Psoriasis vulgaris. The study will compare a blue light treated plaque with an untreated control plaque. Additionally, two intensities of blue light are compared.

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Blue light has been shown to release bioactive nitric oxide (NO) from nitrite and nitrosated proteins found in high concentrations in the skin. This bioactive NO has many physiological functions regulating immune responses, proliferation / differentiation as well as local blood Perfusion of the skin. The study will test the PSO-CT02 device, an new investigational medical device emitting blue light with a peak wavelength of 453nm on treating localised mild Psoriasis vulgaris. It can be worn on the Skin above the effected skin area. In this study Treatment (target) and control area as well as intensity of blue light are randomized. The control area will serve as reference. 50 Patients will treat the target area daily (at least 5 times/week) at home for an initial treatment period of 4 weeks. During those 4 weeks, patients will return to the study site for safety and effectiveness assessments twice. After this initiation period patients will treat their plaque for further 8 weeks (3 times/week). This is followed by a 4 week follow up phase without treatment.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Psoriasis Vulgaris

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Intensity (HI) vs control

PSO-CT02 device: Light wavelength 453nm, high intensity, compared to contralateral untreated control plaque on the same patient.

Group Type EXPERIMENTAL

PSO-CT02

Intervention Type DEVICE

The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.

Low Intensity (LI) vs control

PSO-CT02 device: Light wavelength 453nm, low intensity, compared to contralateral untreated control plaque on the same patient.

Group Type EXPERIMENTAL

PSO-CT02

Intervention Type DEVICE

The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

PSO-CT02

The PSO-CT02 device is a non CE marked investigational medical device that is worn on the affected skin area where it irradiates the Psoriasis plaque for 30 minutes with blue light.

Intervention Type DEVICE

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1. Signed and dated informed consent prior to any study mandated procedure
2. Good health according to physical examination as determined by the Investigator
3. Willing and able to comply with study requirements
4. Skin type I-IV according to Fitzpatrick
5. Mild plaque-type psoriasis vulgaris with a Psoriasis area severity index (PASI) ≤10 and Body surface area (BSA)

≤10 and Dermatology Life quality index (DLQI) ≤ 10 at screening.
6. Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:

1. located on extremities (plaques located on the palms or sole of the feet are not suitable)
2. Both areas located either on lower or upper extremity
3. Can be located on the same extremity
4. Distance between the two study areas \> 10cm (border to border)
5. If lesion is too large to be fully covered, partial treatment possible
7. Aged ≥ 18 years up to \<75 years
8. Reliable method of contraception for women of childbearing potential (i.e. low failure rate less than 1% per year; e.g. oral contraceptives, intra-uterine device \[IUD\] or transdermal contraceptive patch)
9. Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study.

Exclusion Criteria

General

1. Inmates of psychiatric wards, prisons, or other state institutions
2. Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
3. Participation in another clinical trial within the last 30 days
4. Pregnant or lactating women Medical History
5. Photodermatosis and/or Photosensitivity
6. Porphyria and/or hypersensitivity to porphyrins
7. Patients with current diagnosis of erythrodermic, exfoliative or pustular psoriasis
8. Congenital or acquired immunodeficiency
9. Patients with any of the following conditions present on the study areas: Malignoma of the skin or severe actinic damage of the skin, atypical naevi or signs of hyperpigmentation, viral (e.g. herpes or varicella) lesions of the skin, fungal and bacterial skin infections, parasitic infections and atrophic Skin
10. Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Philips Electronics Nederland BV

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Verena von Felbert, PD, Dr.

Role: PRINCIPAL_INVESTIGATOR

Clinic for Dermatology and Allergology, Medical Faculty of the RWTH Aachen, Germany

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Department of Dermatology and Allergology, Medical faculty of the RWTH Aachen

Aachen, , Germany

Site Status

Countries

Review the countries where the study has at least one active or historical site.

Germany

References

Explore related publications, articles, or registry entries linked to this study.

Pfaff S, Liebmann J, Born M, Merk HF, von Felbert V. Prospective Randomized Long-Term Study on the Efficacy and Safety of UV-Free Blue Light for Treating Mild Psoriasis Vulgaris. Dermatology. 2015;231(1):24-34. doi: 10.1159/000430495. Epub 2015 Jun 2.

Reference Type DERIVED
PMID: 26044167 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

PsoriasisCT02

Identifier Type: -

Identifier Source: org_study_id