Phototherapy Protocols. Contents

Classification: Protocols Lead Author: Dr Tsui Ling Additional author(s): N/A Authors Division: Dermatology Unique ID: GSCDerm02(13) Issue number: 2 Expiry Date: February 2017 Contents Section Page Intro Who should read this document 3 Key practice points 3 Policy 4-21 1 TREATMENT PROTOCOL No. 1: Narrowband UVB (TL-01) 4 Phototherapy 2 TREATMENT PROTOCOL No. 2: Systemic PUVA Phototherapy 7 3 TREATMENT PROTOCOL No. 3: Hand and foot PUVA soaks 11 4 TREATMENT PROTOCOL No. 4: Hand and foot oral PUVA 13 5 TREATMENT PROTOCOL No. 5: Bath PUVA Phototherapy 16 6 TREATMENT PROTOCOL No. 6: Missed treatments for UVB, 18 PUVA, hand and foot PUVA 7 TREATMENT PROTOCOL No. 7: Accidental overdose UV 19 protocol 8 TREATMENT PROTOCOL No. 8: Protocol for management of 20 minor adverse events 9 PROTOCOL NO. 9: MED tester protocol 22 10 PROTOCOL NO. 10: Discharge protocol Appendix 23 Document control information (Published as separate document) 24-28 Document Control 24 Policy Implementation Plan 25 Monitoring and Review 25 Endorsement 25 Equality analysis 26 Page 1 of 22

Who should read this document? Phototherapy Unit staff All Dermatology Staff All medical and nursing staff involved in the care of Phototherapy patients Key Practice Points Phototherapy protocols (UVB, PUVA, bath PUVA, hand and foot oral PUVA, hand and foot PUVA soaks), including incremental regimes, are shown. Protocol for management for missed treatments is listed. Protocol for management of accidental UV burns is listed. Protocol for management of minor adverse events is listed. Protocol for use of MED tester is listed. What is new in this version? PROTOCOL no. 9: Discharge protocol added. Page 2 of 22

Treatment Protocol TREATMENT PROTOCOL No. 1: Narrowband UVB (TL-01) Phototherapy 1. Initial irradiation dose: Determine MED (minimal erythema dose) with readings at 24 hours, +/- 3 hours (see Protocol no.9: Narrowband UVB MED testing), except for vitiligo patients or where the patient s skin condition or other circumstances makes testing impractical. 2. Initial irradiation dose: 70% of MED 3. NBUVB to be given three times weekly for most cases, with 2 days between treatments. 4. All patients to wear UV opaque goggles in the cabin. A face shield should also be worn unless significant lesions on face. Males must wear a sock for genital protection. 5. Incremental regime and action to be taken: see also TL01 UVB whole body cabins dose schedule Grade Definition Action E0 No erythema and no report 20% increment of erythema after last treatment E0+1 Patient reports erythema 20% increment but if previous E0+ after last treatment but now then hold dose or 10% increment resolved E1 (mild) Barely perceptible Repeat previous dose then consider E2 (moderate) E3 (severe) E4 (very severe) asymptomatic erythema Well-defined erythema, possibly causing slight manageable discomfort Well-defined symptomatic/painful erythema Painful erythema usually with blistering 10% increments Postpone one treatment if not completely settled; if settled, repeat previous dose and thereafter consider 10% increments No treatment and reviewed by Doctor when possible. When completely settled, 50% of previous dose and then 10% increments No treatment and review by Doctor Page 3 of 22

6. Usual course: 18-24 treatments. Maximum number of treatments per course: 30. Maximum dose per treatment: 4.3 J/cm 2. Lifetime limit of 300 treatments. 7. If develop small areas of erythema: repeat previous dose and apply high factor sunscreen to affected area for one treatment. 8. If develop facial erythema or unacceptable facial pigmentation, a face shield or sunscreen should be used for each treatment. 9. If develop pruritus: encourage use of emollients and antihistamines. 10. If develop Polymorphic Light Eruption (PLE): treat with emollients and very potent topical steroids (eg. Dermovate) immediately after treatment. Postpone treatment if troublesome and reduce to 10 % increments. 11. Cancellation/ missed treatments: see missed treatment protocol. 12. Discharge: see discharge protocol. 13. Documentation: Copies of Treatment summary to be sent to responsible consultant and entered on EPR. 14. Eczema 14.1. UVB Initiating dose: 0.20J/cm 2 14.2. End of phototherapy course taper treatment, with 20% reduction in dose for each treatment: -use last dose at 2/week for 6 weeks, -followed by at 1/week for 6 weeks, -then discharge. 15. Vitiligo 15.1. UVB Initiating dose dose: 0.20J/cm 2 15.2. UVB increment: 10%. 15.3. Minimum 3 monthly treatment. If no response discontinue. 15.4. Follow up by doctor every 3 months. 15.5. Maximum 12 months treatment. 15.6. Clinical photographs at the start of treatment and every three months. 16. Polymorphic Light Eruption (or other photosensitivity disorder) 16.1. UVB Initiating dose: 0.20J/cm 2 16.2. UVB increment: 20%. 16.3. 3/week for 5 weeks, i.e. 15 treatments in total 16.4. If develop PLE during treatment, Page 4 of 22

-If mild, continue with treatment in combination with emollients and topical steroids (eg. Dermovate ointment for body, Eumovate for face). -If severe, treat with emollients and topical steroids AND stop treatment until rash clears, then recommence at a lower dose. -Very severe flares may require oral prednisolone discuss with doctor /book into clinic. 16.5. Encourage patients to keep their sun tolerance topped-up by regular sun exposure throughout spring/summer. 17. Mycosis Fungoides 17.1. UVB initiating dose and incremental doses: as with standard protocol 17.2. UVB suitable for patch stage MF (systemic PUVA for plaque stage MF) 17.3. Continue until skin clear no limit to number of treatments each course or lifetime. 17.4. If maintenance phototherapy is required once skin is clear, consider 1/week or less. Review every 20 maintenance treatments. Page 5 of 22

TREATMENT PROTOCOL No. 2: Systemic PUVA Phototherapy 1. Initial irradiation dose: Skin phototype Start dose J/cm 2 I (Always burn, never tan) 0.5 II (Usually burn, sometimes tan) 1.0 III (Usually tan, sometimes burn) 1.4 IV (Never burn, always tan) 2.0 V (Brown skin) 2.0 VI (Black skin) 2.0 2. PUVA to be given twice weekly for most cases, with 3 days between treatments. 3. 8-Methoxypsoralen (8-MOP) tablets are to be taken 2 hours before irradiation. The dose is calculated according to body surface area(m 2 ) (refer EPR / patient information/ body surface area, or body surface area nomogram). Dose of 8 MOP is 25 mg/m 2 ; dose of 5-MOP is 50 mg/m 2. 3. All patients to wear UV opaque goggles in the cabin. A face shield should also be worn unless significant lesions on face. Males must wear a sock for genital protection. 4. Incremental regime and action to be taken: Grade Definition Action E0 No erythema and no report of erythema after last treatment E0+1 Patient reports erythema after last treatment but now resolved E1 (mild) Barely perceptible asymptomatic erythema E2 Well-defined erythema, (moderate) E3 (severe) E4 (very severe) possibly causing slight manageable discomfort Well-defined symptomatic/painful erythema Painful erythema usually with blistering 40% increment; for 1/week treatment use 20% 40% increment but if previous E0+ then hold dose or 20% increment Repeat previous dose then consider 20% increments Postpone one treatment if not completely settled; if settled, repeat previous dose and thereafter consider 20% increments No treatment and reviewed by Doctor when possible. When completely settled, 50% of previous dose and then 20% increments No treatment and review by Doctor Page 6 of 22

5. Usual course: 18-24 treatments. Maximum number of treatments per course: 30. Maximum dose per treatment: 15 J/cm 2. Lifetime limit of 200 treatments. 6. If develop small areas of erythema: repeat previous dose and apply high factor sunscreen to affected area for one treatment. 7. If develop facial erythema or unacceptable facial pigmentation, a face shield or sunscreen should be used for each treatment. 8. If develop pruritus: encourage use of emollients and antihistamines. 9. If develop Polymorphic Light Eruption (PLE): treat with emollients and very potent topical steroids (eg. Dermovate) immediately after treatment. Postpone treatment if troublesome and reduce to 20 % increments. 10. Cancellation/ missed treatments: see missed treatment protocol. 11. Discharge: see discharge protocol. 13. Documentation: Copies of Treatment summary to be sent to responsible consultant and entered on EPR. 14. Eczema 14.1. PUVA Initiating dose: 0.5J/cm 2 14.2. PUVA increments: 40%. If E1 erythema develops, change to 20% increment. 14.3. End of phototherapy course taper treatment, with 20% reduction in dose for each treatment: -use last dose at 1/week for 6 weeks, -then discharge. 15. Vitiligo 15.1. PUVA Initiating dose dose: 0.5J/cm 2 15.2. PUVA increment: 0.5J/cm 2 until vitiligo is just pink, then maintain or increase by 0.1J/cm 2. 15.3. Minimum 3 monthly treatment. If no response discontinue. 15.4. Follow up by doctor every 20 treatments. 15.5. Maximum 12 months treatment. 15.6. Clinical photographs at the start of treatment and every three months. 16. Polymorphic Light Eruption (or other photosensitivity disorder) 16.1. PUVA Initiating dose: 0.5J/cm 2 Page 7 of 22

16.2. PUVA increment: 40% of previous dose over 4 weeks. 16.3. 2/week for 4 weeks, i.e. 8 treatments in total TREATMENT NUMBER SYSTEMIC PUVA J/cm 2 1 0.5 2 0.7 3 1.0 4 1.4 5 2.0 6 2.8 7 3.9 8 5.5 16.4. If develop PLE during treatment, -If mild, continue with treatment in combination with emollients and topical steroids (eg. Dermovate ointment for body, eumovate for face). -If severe, treat with emollients and topical steroids AND stop treatment until rash clears, then recommence at a lower dose. -Very severe flares may require oral prednisolone discuss with doctor /book into clinic. 16.5. Encourage patients to keep their sun tolerance topped-up by regular sun exposure throughout spring/summer. 17. Mycosis Fungoides 17.1. Systemic PUVA for plaque stage MF (UVB suitable for patch stage MF) 17.2. Initiating dose and increments as for standard protocol. 17.3. Continue until skin clear no limit to number of treatments each course or lifetime. 17.4. If maintenance phototherapy is required once skin is clear, consider 1/week or less. Review every 20 maintenance treatments. 18. Palmoplantar Pustulosis 18.1. Systemic PUVA with or without retinoids. 18.2. If initiating Acitretin midway during phototherapy, hold UV dose for three sessions before increasing dose as per regime. Consider Acitretin dose of 10-20 mg daily. 18.3. Initial irradiation dose: as per standard protocol. 18.4. Maximum no. of treatments: 30 for hands, 40 for feet. 19. Palmoplantar Eczema/ Psoriasis 19.1. Consider hand and foot oral PUVA for hyperkeratotic conditions. 19.2. Maximum no. of treatments: 30 for hands, 40 for feet. Page 8 of 22

TREATMENT PROTOCOL No. 3: Hand and foot PUVA soaks 1. 0.5ml of 8-MOP 1.2% lotion in 2L water (concentration of 3mg/L). 2. Soak for 15 minutes, with a delay of 30 minutes before UVA exposure. 3. For gel (0.005% 8-MOP solution in aqueous gel), apply a thin layer over the affected areas, taking care to avoid applying to surrounding unaffected skin. Then wait for a further 15 minutes prior to treatment. 4. Initial irradiation dose: Skin phototype SOAKS GEL I (Always burn, never tan) 0.5 0.5 II (Usually burn, sometimes tan) 0.5 0.5 III (Usually tan, sometimes burn) 0.5 1.0 IV (Never burn, always tan) 0.5 1.0 V (Brown skin) 0.5 1.0 VI (Black skin) 0.5 1.0 5. Topical PUVA to be given twice weekly for most cases, with 3 days between treatments. 6. All patients to wear UV opaque goggles when having UV irradiation to their hands or feet. 7. Incremental regime and action to be taken: see also Dose to Time Conversion Table Grade Definition Action E0 No erythema and no report of erythema after last treatment E0+1 Patient reports erythema after last treatment but now resolved E1 (mild) Barely perceptible asymptomatic erythema E2 Well-defined erythema, (moderate) E3 (severe) E4 (very severe) possibly causing slight manageable discomfort Well-defined symptomatic/painful erythema Painful erythema usually with blistering 40% increment; for 1/week treatment use 20% 40% increment but if previous E0+ then hold dose or 20% increment Repeat previous dose then consider 20% increments Postpone one treatment if not completely settled; if settled, repeat previous dose and thereafter consider 20% increments No treatment and reviewed by Doctor when possible. When completely settled, 50% of previous dose and then 20% increments No treatment and review by Doctor Page 10 of 22

8. Usual course: 30 treatments. Maximum number of treatments per course: 40. Maximum dose per treatment: 10 J/cm 2. Lifetime limit of 200 treatments. 9. If develop small areas of erythema: repeat previous dose and apply high factor sunscreen to affected area for one treatment. 10. If develop pruritus: encourage use of emollients and antihistamines. 11. If develop Polymorphic Light Eruption (PLE): treat with emollients and very potent topical steroids (eg. Dermovate) immediately after treatment. Postpone treatment if troublesome and reduce to 20 % increments. 12. Cancellation/ missed treatments: see missed treatment protocol. 13. Discharge: see discharge protocol. 14. Documentation: Treatment summary to be entered on EPR and copies to be sent to responsible consultant. Page 11 of 22

TREATMENT PROTOCOL No. 4: Hand and foot oral PUVA 1. Initial irradiation dose: Skin phototype Start dose (J/cm 2 ) I (Always burn, never tan) 0.5 II (Usually burn, sometimes tan) 0.5 III (Usually tan, sometimes burn) 0.5 IV (Never burn, always tan) 0.5 V (Brown skin) 0.5 VI (Black skin) 0.5 2. PUVA to be given twice weekly for most cases, with 3 days between treatments. 3. 8-Methoxypsoralen (8-MOP) tablets are to be taken 2 hours before irradiation. The dose is calculated according to body surface area(m 2 ) (refer EPR / patient information/ body surface area, or body surface area nomogram). Dose of 8 MOP is 25 mg/m 2 ; dose of 5-MOP is 50 mg/m 2. 4. Incremental regime and action to be taken: (ref: Dose to Time Conversion Table) Grade Definition Action E0 No erythema and no report of erythema after last treatment E0+1 Patient reports erythema after last treatment but now resolved E1 (mild) E2 (moderate) E3 (severe) E4 (very severe) Barely perceptible asymptomatic erythema Well-defined erythema, possibly causing slight manageable discomfort Well-defined symptomatic/painful erythema Painful erythema usually with blistering 40% increment; for 1/week treatment use 20% 40% increment but if previous E0+ then hold dose or 20% increment Repeat previous dose then consider 20% increments Postpone one treatment if not completely settled; if settled, repeat previous dose and thereafter consider 20% increments No treatment and reviewed by Doctor when possible. When completely settled, 50% of previous dose and then 20% increments No treatment and review by Doctor Page 12 of 22

TREATMENT PROTOCOL No. 5: Bath PUVA Phototherapy 1. 30ml of 8-MOP 1.2% lotion in 140L water (concentration of 2.6mg/L). 2. Bathe for 15 minutes, followed by immediate UVA exposure. 3. Initial irradiation dose: Skin phototype Start dose J/cm 2 I (Always burn, never tan) 0.2 II (Usually burn, sometimes tan) 0.3 III (Usually tan, sometimes burn) 0.4 IV (Never burn, always tan) 0.5 V (Brown skin) 0.5 VI (Black skin) 0.5 4. Topical PUVA to be given twice weekly for most cases, with 3 days between treatments. 5. All patients to wear UV opaque goggles in the cabin. Face shield should also be worn unless significant lesions present on face. 6. Incremental regime and action to be taken: Grade Definition Action E0 No erythema and no report of erythema after last treatment E0+1 Patient reports erythema after last treatment but now resolved E1 (mild) E2 (moderate) E3 (severe) E4 (very severe) Barely perceptible asymptomatic erythema Well-defined erythema, possibly causing slight manageable discomfort Well-defined symptomatic/painful erythema Painful erythema usually with blistering 40% increment; for 1/week treatment use 20% 40% increment but if previous E0+ then hold dose or 20% increment Repeat previous dose then consider 20% increments Postpone one treatment if not completely settled; if settled, repeat previous dose and thereafter consider 20% increments No treatment and reviewed by Doctor when possible. When completely settled, 50% of previous dose and then 20% increments No treatment and review by Doctor Page 15 of 22

TREATMENT PROTOCOL No. 6: Missed treatments for UVB, PUVA, hand and foot PUVA Ensure treatments have not been cancelled or missed due to erythema, if so follow appropriate protocol incremental regime. Missed 1 treatment Missed 2 treatments Missed 3 treatments Missed 4-6 treatments Missed >6 treatments UVB: Continue with previous increments. PUVA: Repeat previous dose. Repeat previous dose. Give dose before previous dose. Give 50% of previous dose. Refer back to consultant. Missed >3 weeks due to holiday or sickness Consult starting dose. Page 17 of 22

TREATMENT PROTOCOL No. 7: ACCIDENTAL UV OVERDOSE PROTOCOL 1. General points 1.1. Contact patient immediately and explain. 1.2. Make all efforts for patient to re-attend the phototherapy unit immediately for assessment and treatment. Prompt action will minimise UV damage. 1.3. Phototherapy Consultant, on call registrar, and GP to be informed. 1.4. Where a large error has occurred ( eg.>50% UVB dose, or >75% UVA dose), consider hospital admission for overnight observation and treatment. 1.5. If patient can be treated at home, frequent contact should be maintained. 1.6. Accurate documentation is vital; ensure all discussions are documented. All details to be entered in phototherapy notes and a copy sent for filing in main hospital notes; 1.7. Complete Trust incident form. 1.8. UVB-induced burns reach maximum intensity at 24-36 hours, and fade thereafter. UVA-induced burns reach maximum intensity at 2-3 days for oral PUVA, or 3-5 days for bath PUVA. 2. Specific Treatment (give hospital prescription) 2.1. Oral Prednisolone to be given: 40 mg stat, followed by 30 mg /day for five days. 2.2 Topical treatment Dermovate ointment B.D. An emollient QID 2.3 Prescribe analgesics. 3. Follow-up 3.1. Offer daily dressings / nursing assessment to patient. 3.2. Review by medical staff within three days. Page 18 of 22

TREATMENT PROTOCOL No. 8: PROTOCOL for MANAGEMENT OF MINOR ADVERSE EVENTS 1. Acute adverse effects of PUVA 1.1. Severe burns - see Protocol 6 1.2. Mild/localized burning emollients, Dermovate ointment, apply sunscreens to affected area 1.3. Erythema grade level of erythema and manage accordingly 1.4. PUVA itch uncommon, usually chest and arms. Emollients and antihistamines to tide patients over the first couple of week of PUVA. Occasionally this may be painful ; PUVA-pain consider changing to 5 MOP or bath PUVA. 1.5. PUVA blisters this is usually a phototoxic reaction, involving hands and feet. Consider concomitant photosensitizing drugs (eg. NSAID, thiazides, diuretics, tetracyclines, Neotigason). 1.6. Tanning people with skin type IV and V may not consider tanning to be desirable. Patients with vitiligo may find tanning of normal skin worsening the overall appearance. 1.7. Provocation of PLE Prophylactic application of Dermovate ointment after each treatment session. 1.8. Reaction of Cold Sores If susceptible to cold sores, apply lip sunscreen or visor throughout duration of treatment. If develop cold sores early application of acyclovir cream five times a day. 1.9. Facial seborrhoeic dermatitis - affects about 5% of patients and is not very responsive to topical corticosteroids. 1.10. Other side effects 1.10.1. photo-onycholysis, 1.10.2. nail pigmentation 1.10.3. facial hair growth in women, scalp hair growth in men 1.10.4. curling of previous straight hair 1.10.5. folliculitis and milia 1.10.6. pseudoporphyria 1.10.7. lichenoid eruption 2. Acute adverse events of UVB 2.1. Severe burns see protocol 7. 2.2. Transient erythema common; starts a few minutes after treatment and persist for up to 8 hours. It clears completely. Next erythemal assessment prior to the next dose of UVB should not be affected i.e. E0+ reaction. 2.3. Itch usually during first 2 weeks of treatment. Emollients and antihistamines. 2.4. Cold sores susceptibility to this should be prevented with lip sunscreen or visor. Treat with topical or oral acyclovir. 2.5. Blistering occurs at the margins of psoriasis plaques, especially on plaques around the mid and lower abdomen and buttocks. Page 19 of 22

PROTOCOL No. 9: MED Tester protocol MED (Minimum Erythema Dose) testing should be carried out on all patients prior to a course of narrowband UVB (TL01) phototherapy, except for vitiligo patients or where the patient's skin condition or other circumstances makes testing impractical. 1. Confirm that the patient will be able to return for evaluation of their skin response 24 hours (+/- 3 hours) after the test exposure. 2. Indentify a suitable skin area to which the MED tester can be applied. The area should have limited normal sun exposure, such as the inner surface of the forearm, and be clear of skin rashes or other skin surface changes that might complicate the assessment of the MED test. Ensure that the full area of the face of the MED tester will lie in contact with the patient's skin without undue pressure. 3. Select the test exposure time to be used on depending on the assessment of the patient's skin type. A shorter exposure time is used for Skin Types I and II, and a longer time for Skin Type III and above. 4. Prepare the MED tester and give the test exposure according to the local operating instructions. 5. Immediately the test exposure ends, mark the patient's skin beside the test area to indicate the orientation of the test area. Use a waterproof marker. Avoid marks within the actual test area. 6. In the patient's record, note the exposure time used. 7. After use, clean the MED tester with SaniCloth Detergent Wipes. 8. When the patient returns for the 24 hour response reading, examine the test area in a good light and decide which of the 10 individual test patches is just showing an erythema response. 9. From the comparison table for MEDs and phototherapy start doses, read off the MED for the appropriate test patch. Note the MED in the patient's record. 10. Also read off the corresponding phototherapy start dose and note this in the patient's record. Start doses are approximately 70% of the MED. 11. If the MED test result is unclear, e.g. all test patches with higher doses than the apparent MED patch do not also show erythema, use the standard starting doses based on skin type and skin disease. 12. Once the start dose has been determined, commence phototherapy treatment that same day. Page 20 of 22

PROTOCOL No. 10: Discharge protocol Treatment usually continues until the patient is clear, condition is no longer improving, has 4 treatments at MRA (minimal residual activity) or is stopped on medical advice. A phototherapy summary is sent to the referring clinician on completion of treatment. The following is a guide to follow-up care: 1. Patients completing treatment having incurred no problems discharge to referring clinician. 2. Patients who have failed to attend discharge to referring clinician. If patient has had mitigating circumstances, consider discussing with referring clinician. 3. Patients who are known to flare quickly when treatment is completed should be advised to contact the referring clinician if they develop a flare up or have concerns. 4. Patients attending for desensitisation who may require repeated treatment should be reviewed early the following year by the phototherapy clinic as appropriate. Page 21 of 22

Standards (section number should follow on from the preceding section) Minimum service provision standards using the Phototherapy Review toolkit, as well as recommended Phototherapy Guidelines, as suggested by the British Association of Dermatologists can be viewed here: http://www.bad.org.uk/site/1511/default.aspx Explanation of terms Terms as described in document. References and Supporting Documents For recommended phototherapy guidelines, see British Association Dermatologists website/phototherapy/phototherapy Service Provision in the UK http://www.bad.org.uk/site/1511/default.aspx Roles and responsibilities Lead Clinician: Dr Tsui Ling Lead Nurse: Sister Melanie Casey Medical Physicist: Dr Donald Allan (donald.allan@christie.nhs.uk) Page 22 of 22