Blue Light for Treating Psoriasis Vulgaris

NCT02004847 | Completed Results

• 1 other identifier: PsoriasisCT02
• Study Type: interventional
• Target: 47
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

• Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity (HI) Group) as Compared to the Control Area at End of Treatment (Visit 7, Week 12).

  In this study only the "local" PASI (also called local psoriasis severity index - LPSI) was evaluated. The investigator evaluated and graded the severity of erythema, induration, and scaliness as the key symptoms of psoriasis on the study areas using the following scale: 0 = no sign, 1 = slight, 2 = moderate, 3 = marked,4 = very marked A total severity score was calculated as the sum of the three symptom ratings (range 0-12 whereas 0 (best) - 12 (worst)).

  baseline and week 12

Secondary Outcomes (11)

• Change From Baseline of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Treatment During the Attack Period (Week 4, Visit 5)

  baseline and week 4

• Change From Week 12 of the Local Psoriasis Area Severity Index (PASI) of the Target Area (High Intensity) as Compared to the Control Area at End of Follow-up

  Week 12 and week 16

• Change From Baseline (Visit 2) of the Local Psoriasis Area Severity Index (PASI) of the Target Area (Low Intensity (LI) Group) as Compared to the Control Area by Week.

  baseline and week 4, 12, 16

• Difference in Change From Baseline of Local Psoriasis Area Severity Index (PASI) Between Target and Control Area of the High Intensity (HI) Group as Compared to the Low Intensity (LI) Group

  baseline and week 4, 8, 16

• Change From Baseline of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area

  baseline and week 4, 12

Other Outcomes (4)

• Hyperpigmentation of "Normal Skin Areas" Surrounding the Target Area Exposed to Blue Light and Control Area Not Exposed to Blue Light- Evaluation by Mexameter

  week 4, 12, 16

• Adverse Events (Serious and Non-serious)

  week 0, 1, 2, 4, 8, 12, 16

• Thermal Comfort

  week 12

Study Arms (2)

High Intensity (HI) vs control

EXPERIMENTAL

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

Device: PSO-CT02

Low Intensity (LI) vs control

EXPERIMENTAL

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

Device: PSO-CT02

Interventions

PSO-CT02 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.

High Intensity (HI) vs control; Low Intensity (LI) vs control

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed and dated informed consent prior to any study mandated procedure
• Good health according to physical examination as determined by the Investigator
• Willing and able to comply with study requirements
• Skin type I-IV according to Fitzpatrick
• 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.
• Presence of two comparable psoriatic plaques suitable to be defined as study areas as follows:
• located on extremities (plaques located on the palms or sole of the feet are not suitable)
• Both areas located either on lower or upper extremity
• Can be located on the same extremity
• Distance between the two study areas \> 10cm (border to border)
• If lesion is too large to be fully covered, partial treatment possible
• Aged ≥ 18 years up to \<75 years
• 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)
• Willing to abstain from excessive sun / UV exposure (e.g. sunbathe, solarium) during the course of the study.

You may not qualify if:

• General
• Inmates of psychiatric wards, prisons, or other state institutions
• Investigator or any other team member involved directly or indirectly in the conduct of the clinical study
• Participation in another clinical trial within the last 30 days
• Pregnant or lactating women Medical History
• Photodermatosis and/or Photosensitivity
• Porphyria and/or hypersensitivity to porphyrins
• Patients with current diagnosis of erythrodermic, exfoliative or pustular psoriasis
• Congenital or acquired immunodeficiency
• 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
• Patients with genetic deficiencies attached with increased sensitivity to light or increased risk to dermatologic cancer (i.e. Xeroderma pigmentosum, Cockayne Syndrome, Bloom- Syndrome)

Sponsors & Collaborators

• Philips Electronics Nederland BV: lead

Study Sites (1)

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

Aachen, 52074, Germany

Location

Related Publications (1)

• 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.

  PMID: 26044167 DERIVED

Results Point of Contact

• Title: Prof. Dr. Matthias Born
• Organization: Philips GmbH Innovative Technologies Aachen

matthias.born@philips.com

+491735321764

Study Officials

• Verena von Felbert, PD, Dr.

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

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 19, 2013
• First Posted: December 9, 2013
• Study Start: September 1, 2013
• Primary Completion: May 1, 2014
• Study Completion: May 1, 2014
• Last Updated: December 18, 2015
• Results First Posted: November 18, 2015

Record last verified: 2015-11

Locations

DE (1)