An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients

Psoriasis Clinical Trial

Official title:

An Open-Label, Pilot Study to Evaluate the Efficacy of Narrowband Ultraviolet-B Phototherapy Three Times Weekly for Twelve Weeks in Moderate-to-Severe Psoriasis Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03392337
• Other study ID #: PTC02
• Status: Recruiting
• Phase: N/A
• Start date: November 7, 2017
• Est. completion date: January 1, 2020

Study information

• Verified date: January 2019
• Source: Psoriasis Treatment Center of Central New Jersey
• Contact: Jerry Bagel, MD
• Phone: 6094434500
• Email: dreamacres1[@]aol.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

A single center study of 30 patient receiving Narrowband UVB phototherapy three times weekly for 12 weeks. Patients will be evaluated through week 36 to evaluate maintenance of response.

Description:

30 subjects will be treated with increasing doses of Narrowband Ultraviolet phototherapy three times weekly for 12 weeks. Patients will then be evaluated every 6 weeks through week 36 to determine maintenance of response.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: January 1, 2020
• Est. primary completion date: December 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female adults = 18 years of age.

2. Diagnosis of chronic plaque-type psoriasis for at least 6 months

3. Moderate to Severe plaque psoriasis as defined by BSA =10 PASI =12 IGA =3

4. Able to give written informed consent prior to performance of any study related procedures

5. Subject is able to attend Narrowband UVB phototherapy sessions three times a week and all other protocol specified visits

6. Subject must be in general good health (except for psoriasis) as judged by the Investigator, based on medical history, physical examination.

Exclusion Criteria:

1. Forms of psoriasis other than chronic plaque-type (e.g., pustular, erythrodermic, and/or guttate psoriasis) or drug induced psoriasis

2. History of photosensitivity

3. Subject has used ustekinumab and/or anti-IL-17 biologic therapy within 24 weeks or other experimental or commercially available biologic immune modulator(s) within 12 weeks prior to the first IP dose.

4. Use of any investigational drug within 4 weeks prior to randomization, or within 5 pharmacokinetic/pharmacodynamic half lives, if known (whichever is longer).

5. Use of oral systemic medications for the treatment of psoriasis within 4 weeks (includes, but not limited to, oral corticosteroids, methotrexate, acitretin, apremilast and cyclosporine).

6. Patient used topical therapies to treat within 2 weeks of the Baseline Visit (includes, but not limited to, topical corticosteroids, vitamin D analogs, or retinoids).

7. Initiated within 3 months, planned initiation of, or changes to, concomitant medications that could affect psoriasis vulgaris (e.g. beta blockers, antimalarial drugs, lithium, ACE inhibitors ) during the trial

8. Active infections requiring antibiotics in the 2 weeks prior to Baseline

9. Patient received UVB phototherapy within 4 weeks of Baseline.

10. Patient received PUVA phototherapy within 4 weeks of Baseline.

Related Conditions & MeSH terms

• Psoriasis

Intervention

Device:
• Narrowband UVB phototherapy
Ultraviolet B phototherapy

Locations

Country	Name	City	State
United States	Elise Nelson	East Windsor	New Jersey

Sponsors (1)

Lead Sponsor	Collaborator
Psoriasis Treatment Center of Central New Jersey

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Psoriasis area severity index score	PASI 75	12 weeks
Secondary	Physicians Global Assessment	PGA improvement	12 weeks
Secondary	Body Surface Area	BSA improvement	12 weeks
Secondary	Physician's Global Assessments multiplied by Body surface area	PGA x BSA	12 weeks