Trial Outcomes & Findings for The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease (NCT NCT00494975)

Results Overview

a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus. 0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions

Recruitment status

COMPLETED

Study phase

NA

Target enrollment

21 participants

Primary outcome timeframe

VAS score at baseline and after 6 -week phototherapy

Results posted on

2011-01-27

Participant Flow

Participant milestones

Participant milestones
Measure	Ultraviolet A Phototherapy a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )	Narrow Band Ultraviolet B Phototherapy a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
Overall Study STARTED	10	11
Overall Study COMPLETED	8	10
Overall Study NOT COMPLETED	2	1

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

The Effect of Phototherapy on Pruritus of Patients With Chronic Kidney Disease

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Ultraviolet A Phototherapy n=10 Participants a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )	Narrow Band Ultraviolet B Phototherapy n=11 Participants a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).	Total n=21 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	5 Participants n=5 Participants	7 Participants n=7 Participants	12 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants	4 Participants n=7 Participants	9 Participants n=5 Participants
Age Continuous	63.2 years STANDARD_DEVIATION 11.3 • n=5 Participants	60.9 years STANDARD_DEVIATION 11.5 • n=7 Participants	62.0 years STANDARD_DEVIATION 11.2 • n=5 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	5 Participants n=7 Participants	10 Participants n=5 Participants
Sex: Female, Male Male	5 Participants n=5 Participants	6 Participants n=7 Participants	11 Participants n=5 Participants
Region of Enrollment Taiwan	10 participants n=5 Participants	11 participants n=7 Participants	21 participants n=5 Participants

PRIMARY outcome

Timeframe: VAS score at baseline and after 6 -week phototherapy

a VAS is a horizontal line, 100 mm in length. The patient marks on the line the point that they feel represents their perception of their pruritus. 0 (no pruritus) - 10 (most severe pruritus) The investigator will determine the pruritic intensity at baseline, every 3 sessions by VAS score, and by detailed questionnaire at baseline and after 18 sessions

Outcome measures

Outcome measures
Measure	Ultraviolet A Phototherapy n=8 Participants a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVA lamps (F72T12/BL9/HO UVA, National Biological Corporation, OH, U.S.A. )	Narrow Band Ultraviolet B Phototherapy n=10 Participants a UV irradiation cubicle (HOUVA II, National Biological Corporation, OH, U.S.A.) equipped with 24 UVB lamps (TL100W/01 311NB UVB, Philips Company, Eindhoven, The Netherlands).
Visual Analogue Scale (VAS) Score for Pruritus	-3.38 Units on a scale Standard Deviation 2.59	-3.53 Units on a scale Standard Deviation 3.49

SECONDARY outcome

Timeframe: at baseline and after 18 sessions

Outcome measures

Outcome data not reported

Adverse Events

Ultraviolet A Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Narrow Band Ultraviolet B Phototherapy

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Ko Mei-Ju

Dermatology

Phone: 886-223123456

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place