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The use of ultraviolet light photochemotherapy Polarised Ultra Violet A [PUVA] in the oral cavity in conjunction with a oral photo-sensitiser [5-methoxypsolaren or 8-methoxypsoralen] for oral graft-versus- host disease [GVHD] in allogeneic bone marrow transplant patients [ABMT].

The use of ultraviolet light photochemotherapy Polarised Ultra Violet A [PUVA] in the oral cavity in conjunction with a oral photo-sensitiser [5-methoxypsolaren or 8-methoxypsoralen] for oral graft-versus- host disease [GVHD] in allogeneic bone marrow transplant patients [ABMT].

Status
Recruiting
Phases
Phase 1
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12613000330741
Acronym
PUVA study
Enrollment
10
Registered
2013-03-25
Start date
2010-02-02
Completion date
2024-02-01
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

Patient will recieve a controlled exposure of UVA using a Spectraline wand with a an oral photosensitiser such as 8 MOP or 5 MOP. Exposure to the UVA starts at 15 sec and increments by 15 secs once a week to a maximium exposure of 60 secs. All patients will be offered a total of 40 treatments of the combined therpay. Patients will be evaluated by their specialist at treatments 1, 10, 20 and at treatment 40 or termination/withdrawal. Early conclusion or treatment or temporary interuptions are permitted if remission is attained.

Interventions

Patient will recieve a controlled exposure of UVA using a Spectraline wand (A pencil lamp source of UVA light placed in the oral cavity) with the oral photosensitiser 8-Methoxypsoralen (MOP) at a dose of 0.6mg/kg or 5 MOP at a dose of 1.2mg/kg given two hours before each treatment. Exposure to the UVA light starts at 15 sec and increments by 15 secs once a week to a total of 60 secs. All patients will be offered a total of 40 treatments with an average of four treatments per week. Patients comp

Patient will recieve a controlled exposure of UVA using a Spectraline wand (A pencil lamp source of UVA light placed in the oral cavity) with the oral photosensitiser 8-Methoxypsoralen (MOP) at a dose of 0.6mg/kg or 5 MOP at a dose of 1.2mg/kg given two hours before each treatment. Exposure to the UVA light starts at 15 sec and increments by 15 secs once a week to a total of 60 secs. All patients will be offered a total of 40 treatments with an average of four treatments per week. Patients complete the treatment using the same oral photosensitiser they start with, and supply/ availability of the drug determines which one the patient uses.

Sponsors

St Vincent's Hospital, Sydney
Lead SponsorHospital

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years
Healthy volunteers
No

Inclusion criteria

Undergone Allogeneic Stem cell transplant with clinical diagnosis of oral GVHD and any degree or oral symptoms leading to pain, discomfort and interfere with oral intake. Histological confirmation not required.

Exclusion criteria

Sensivity to sunscreens and photosensitisers. Known photodermatoses. Foreseeable intense exposure to solar or UV exposure except study related. unable to take tablets

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026