Submitted by: Maria Gracia R. Concepcion 2017-08-15 00:00:00 Last Updated by: Maria Gracia R. Concepcion 2017-10-04 07:54:55 Export to PDF

Narrowband ultraviolet B phototherapy versus visible light in HIV pruritus: a randomized controlled trial

PHRR171003-001658

RGAO-2017-0239

Unspecified

Narrowband ultraviolet B phototherapy versus visible light in HIV pruritus: a randomized controlled trial

The human immunodeficiency virus (HIV) has been receiving much worldwide attention in the recent years. HIV infection presents with various skin manifestations, and usually correlates with the level of immunosuppression (CD4 levels) and viral loads. Pruritus comprises majority of the skin concerns, whether it is primary or related to a specific disease condition. Chronic pruritus, defined as pruritus more than 6 weeks duration, has a negative impact on quality of life (QOL) of HIV patients. Various therapies for intractable pruritus in HIV patients have been used, which include topical corticosteroids, oral steroids, antihistamines, and antidepressants such as selective serotin-norepinephrine reuptake inhibitor, anticonvulsants, and topical moisturizers, among others. There is some evidence that phototherapy, particularly narrowband UVB, helps in decreasing severity of pruritus in patients with HIV. At present, there is still no standard of therapy for pruritus in patients with HIV. Phototherapy may be further explored as therapy for HIV pruritus. This could potentially decrease the need for oral medications for pruritus, especially in patients already on multiple oral drugs, with increased risk for drug interactions and adverse events.

Background: The human immunodeficiency virus (HIV) has been receiving much worldwide attention in the recent years. HIV infection presents with various skin manifestations, and usually correlates with the level of immunosuppression (CD4 levels) and viral loads. Pruritus comprises majority of the skin concerns, whether it is primary or related to a specific disease condition. Chronic pruritus, defined as pruritus more than 6 weeks duration, has a negative impact on quality of life (QOL) of HIV patients. Various therapies for intractable pruritus in HIV patients have been used, which include topical corticosteroids, oral steroids, antihistamines, and antidepressants such as selective serotin-norepinephrine reuptake inhibitor, anticonvulsants, and topical moisturizers, among others. There is some evidence that phototherapy, particularly narrowband UVB, helps in decreasing severity of pruritus in patients with HIV. At present, there is still no standard of therapy for pruritus in patients with HIV. Phototherapy may be further explored as therapy for HIV pruritus. This could potentially decrease the need for oral medications for pruritus, especially in patients already on multiple oral drugs, with increased risk for drug interactions and adverse events.

Objectives: To determine the efficacy and safety of an 8-week narrowband UVB phototherapy versus a visible-light comparator (sham) on HIV pruritus.

Methodology:  This study is randomized, double-blinded (patient and outcome assessor) placebo and active controlled trial. Participants of the study are patients diagnosed with HIV, with moderate to severe pruritus determined by visual analogue scale. Twenty four patients will be recruited, 12 patient in each arm. Phototherapy will be administered to the whole body surface 2 sessions per week for a total of 16 sessions. NB-UVB will be started at  150 mJ/cm2. In the absence of side effects, such as UV-induced erythema and burning sensation, the dose will be increased by 15% every session. The dose will be adjusted based from the modified version of the NB-UVB Skin Type protocol. The control group will receive a time-matched exposure to visible light. Outcome assessment will be done every session using standard data collection forms and validated assessment tools for 8 weeks. Patients will be followed-up 2 weeks, 4 weeks and 8 weeks after the treatment.

Data Management and Analysis: Data will be encoded in standardized encoding forms in Microsoft Excel and will be analyzed using STATA version 13.0. Descriptive data (frequencies, percentages and mean scores) will be tallied for baseline characteristics of both groups. Within and between group analysis using repeated measures analysis of variance (ANOVA) will be employed. Intention to treat analysis will be done. For missing data, the last observation will be carried forward. A sensitivity analysis will be performed, should there be a significant number of dropouts observed in the study.

Research question: What is the efficacy and safety of narrow UVB phototherapy versus a visible-light comparator (sham) on the intensity of pruritus and quality of life in patients with HIV pruritus?

Regime Classification Priority
2010 - 2016 Health Technology Development Drug Discovery and Development
Start Date Duration in Months Target Completion Date Actual Completion Date
2017-07-01 7 2018-02-01 2018-02-01

Ongoing

Institution Classification Region LTO #
Philippine General Hospital, Section of Dermatology Government NCR LTO-3000001863742
Institution Amount Region
Self-funded N/A None
Name E-Mail Phone Number Postal Address
Jolene Kristine G. Gatmaitan-Dumlao jolenegatmaitan@gmail.com 554-8400, local 5105-5016, 526-2397 UP-Philippine General Hospital, Section of Dermatology Taft Ave., Manila
Name E-Mail Phone Number Postal Address
Jolene Kristine G. Gatmaitan-Dumlao jolenegatmaitan@gmail.com 554-8400, local 5105-5016, 526-2397 UP-Philippine General Hospital, Section of Dermatology Taft Ave., Manila
Name Expertise Affiliation
Jolene Kristine G. Gatmaitan, MD Dermatology Philippine General Hospital, Section of Dermatology
Aznaida T. Pandapatan, MD Dermatology Philippine General Hospital, Section of Dermatology
Leah Antoinette M. Caro-Chang, MD Dermatology Philippine General Hospital, Section of Dermatology
Ma. Lorna F. Frez, MD, FPDS Dermatology Philippine General Hospital, Section of Dermatology
Winlove P. Mojica, MD Dermatology Philippine General Hospital, Section of Dermatology
Shahara M. Abalos, MD Dermatology Philippine General Hospital, Section of Dermatology
Project Location Institutional Ethics Review Board
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A
Philippine General Hospital, Section of Dermatology N/A

HIV

Severity of Pruritus

Quality of life, incidence of adverse events, cosmetic acceptability

Recruiting

  • Philippines

Clinical Trial

Unspecified

2017-06-22

None

INCLUSION CRITERIA

  •     Adults, male or female, > 18 years old
  •     Patients with positive HIV status
  •     Moderate to severe pruritus on visual analogue scale (VAS), pruritus score of >4 16
  •     Can read, understand, and follow instructions in English
  •     With consent to participate

EXCLUSION CRITERIA

  • HIV patients with symptoms or clinical conditions falling under clinical stage 3 and 4 of the WHO clinical staging of HIV/AIDS for adults and adolescent

                  i.e. unexplained chronic diarrhea, severe presumed bacterial infection, acute necrotizing ulcerative stomatitis, pneumocystis pneumonia, HIV encephalopathy, rest of conditions found here: https://www.ncbi.nlm.nih.gov/books/NBK374293/

  • Patients with existing erythroderma and/or known photodermatitis, both HIV-related or not HIV-related

                  i.e. chronic actinic dermatitis, polymorphic light eruption, actinic prurigo, chronic actinic dermatitis (CAD), porphyria cutanea tarda, photosensitive granuloma annulare, and lichenoid photoeruption

  •     Patients with intake of known photosensitizing drugs
  •     Patients with history of prior non-melanoma skin cancer
  •     Pregnancy and/or lactating women
  •     Non-English speakers: the 5D itch scale is not scientifically valid in language other than English
  •     No consent to participate


WITHDRAWAL CRITERIA

  •     Any patient developing HIV-related disease conditions under clinical stage 3 and 4
  •     Any patient developing severe blistering and vesiculation of the skin prompting immediate medical attention
  •     May withdraw anytime from the study

Interventional

Narrowband UVB Phototherapy

Narrowband UVB light (wavelength 280-315nm) given at an initial dose of 150 mJ/cm2

Randomized

Double Blind

Patient and Outcome Assessor

Parallel

Treatment

Phase II/III

24

Unspecified

Unspecified

01 Jul 2017

Utilization Utilization Info
No records found.

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