N/A
Completed N=47
Blue Light for Treating Psoriasis Vulgaris
Source: ClinicalTrials.gov NCT02004847 ↗Enrolled (actual)
47
Serious AEs
0.0%
Results posted
Nov 2015
Primary outcomePrimary: 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). — -2.38; -1.46 units on a scale — p=0.0005
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.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY 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). |
-2.38; -1.46 | 0.0005 sig |
| SECONDARY 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) |
-1.92; -1.33 | 0.0036 sig |
| SECONDARY 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 |
-0.22; -0.43 | 0.3075 |
| SECONDARY 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. |
-1.83; -0.87; -2.78; -2.04; -3.00; -2.50 | 0.0140 sig |
| SECONDARY 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 |
-1.92; -1.33; -1.83; -0.87; -2.25; -1.50 | — |
| SECONDARY 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 |
3.38; 1.00; 0.13; 2.87; -0.38; -0.58 | — |
| SECONDARY Change From Week 12 (End of Treatment) of Erythema Evaluated by Mexameter of the Target Area of High Intensity (HI) and Low Intensity (LI) as Compared to the Control Area at End of Follow-up |
-2.26; 2.00; -1.64; 3.23 | — |
| SECONDARY System Usability Scale |
88.37; 88.53 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) |
-0.75; -0.36 | — |
| SECONDARY Time to First Use of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) |
46.35; 48.25 | — |
| SECONDARY Total Duration of Topical Co-treatment With Vitamin D of High Intensity (HI) and Low Intensity (LI) |
62.65; 53.44 | — |
| SECONDARY Adverse Device Events (Serious and Non-serious) |
0; 0; 0; 0 | — |
Eligibility Criteria
Inclusion Criteria
- 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.
Exclusion Criteria
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)
Data sourced from ClinicalTrials.gov (NCT02004847). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.