Euro PDT 2014 highlights - European society for Photodynamic

Report
1 4 TH ANNUAL CONGRESS
Euro PDT 2014 highlights
Nice, April 4th and 5th 2014
1 4 TH ANNUAL CONGRESS
Euro PDT 2014 highlights
Pre-treatment
•
•
•
•
Influence of pre-treatment on face and scalp AK on efficacy and tolerability. Patrick Gholam, Heidelberg, Germany
Pretreatment with calcipotriol enhances MAL-induced PpIX formation. A murine study. Christiane Bay, Copenhagen, Denmark
Fx Laser + Daylight-PDT vs Daylight-PDT vs c-PDT vs laser alone in OTR. Katrine Togsverd-Bo, Copenhagen, Denmark
Conventional MAL-PDT with microneedling on actinically damaged skin. Luis Torezan, Sao Paulo, Brazil
New approaches for PDT
• Results of 2 randomised, controlled, phase III studies with Daylight-PDT in Australia and Europe. Jean-Philippe Lacour, Nice, France
• A new approach to a gentle PDT treatment. Stine Regin Wiegell, Copenhagen, Denmark
• Pulse PDT: A promising new way to reduce inflammation in PDT without reducing efficacy. Hans Christian Wulf, Copenhagen, Denmark
From oncology to antimicrobial PDT
• DEBATE: PDT in sBCC Studies results => when choosing PDT for sBCC. Rianne M.J.P. Gerritsen, Njimegen, The Netherlands & Nicole KellenersSmeets, Maastricht, The Netherlands
• Patch-PDT: convenient and effective for actinic cheilitis? Sonja Radakovic, Vienna, Austria
• PDT field treatment vs. lesion treatment in AK. Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
• MAL-PDT vs Imiquimod 5% cream for skin cancer prevention. Elena Sotirou, Thessaloniki, Greece
• MAL-PDT for mycosis fungoides: a prospective open study and review of literature . Gaelle Quéreux, Nantes, France
• Antimicrobial PDT in chronic leg and foot ulcers. Stan Brown, Leeds, UK
• Clinical and microbiological healing of onychomycosis after 3 sessions of conventional MAL-PDT vs placebo. Yolanda Gilaberte, Huesca, Spain
Abbreviations
1 4 TH ANNUAL CONGRESS
Euro PDT 2014 highlights
Pre-treatment
•
•
•
•
Influence of pre-treatment on face and scalp AK on efficacy and tolerability. Patrick Gholam, Heidelberg, Germany
Pretreatment with calcipotriol enhances MAL-induced PpIX formation. A murine study. Christiane Bay, Copenhagen, Denmark
Fx Laser + Daylight-PDT vs Daylight-PDT vs c-PDT vs laser alone in OTR. Katrine Togsverd-Bo, Copenhagen, Denmark
Conventional MAL-PDT with microneedling on actinically damaged skin. Luis Torezan, Sao Paulo, Brazil
Enhancing PDT tolerance
• Results of 2 randomised, controlled, phase III studies with Daylight-PDT in Australia and Europe. Jean-Philippe Lacour, Nice, France
• A new approach to a gentle PDT treatment. Stine Regin Wiegell, Copenhagen, Denmark
• Pulse PDT: A promising new way to reduce inflammation in PDT without reducing efficacy. Hans Christian Wulf, Copenhagen, Denmark
From oncology to antimicrobial PDT
• DEBATE: PDT in sBCC Studies results => when choosing PDT for sBCC. Rianne M.J.P. Gerritsen, Njimegen, The Netherlands & Nicole KellenersSmeets, Maastricht, The Netherlands
• Patch-PDT: convenient and effective for actinic cheilitis? Sonja Radakovic, Vienna, Austria
• PDT field treatment vs. lesion treatment in AK. Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
• MAL-PDT vs Imiquimod 5% cream for skin cancer prevention. Elena Sotirou, Thessaloniki, Greece
• MAL-PDT for mycosis fungoides: a prospective open study and review of literature . Gaelle Quéreux, Nantes, France
• Antimicrobial PDT in chronic leg and foot ulcers. Stan Brown, Leeds, UK
• Clinical and microbiological healing of onychomycosis after 3 sessions of conventional MAL-PDT vs placebo. Yolanda Gilaberte, Huesca, Spain
Abbreviations
1 4 TH ANNUAL CONGRESS
Influence of pre-treatment with urea cream 40%
on face and scalp AK on efficacy and tolerability.
Patrick Gholam, Heidelberg, Germany
METHODS:
Retrospective monocentric study
44 subjects aged 73.2 ± 7.7 years (mean±SD) with multiple grade I-II AK (mean 11.1 per patient) on the
forehead (mean field size 117 cm²):
15 patients with curettage (CUR) prior to MAL application
15 patients with 10% salicylic acid (SA) one day prior to MAL-PDT (field application)
14 patients with 40% urea (UR) one day prior to MAL-PDT (field application)
Pain was assessed during illumination, efficacy was assessed at 1 month (1MAL-PDT session)
Curettage
N=15
10% Salicylic acid
N=15
40% Urea
N=14
p value
Lesion CR (%)
68.5
61.4
60.8
NS
Mean pain score
+/-SD
4.4 +/- 2.1
6.32 +/- 2.7
6.1 +/- 1.8
<.005
1 4 TH ANNUAL CONGRESS
Influence of pre-treatment with urea cream 40%
on face and scalp AK on efficacy and tolerability.
Patrick Gholam, Heidelberg, Germany
RESULTS:
Significantly more pain with keratolytic pretreatment
No difference in lesion response rates
Side effects:
Curettage: slight bleeding and pain
Pretreatment with SA or UR: mild erythema in most patients
In the UR group 2 patients showed distinct irritation of the skin and one patient an erosion
Cosmetic result 4 weeks after PDT was excellent in all three groups (no scars, no hyper/hypopigmentation)
CONCLUSION:
Keratolytic pretreatment with urea and salicylic acid compared to curettage:
comparable lesion response rates and cosmetic outcome
increase in pain during PDT and pronounced local reactions.
1 4 TH ANNUAL CONGRESS
Pretreatment with calcipotriol enhances MALinduced PpIX formation. A murine study.
Christiane Bay, Copenhagen, Denmark
BACKGROUND:
PpIX is highly correlated with terminal cell differentiation. Since vitamin D is a pro-differentiating
hormone, we examined the potential of calcipotriol (CAL) to intensify PpIX fluorescence from MAL.
METHODS:
Calcipotriol cream (50 μg/g) was applied for 3 days prior to topical incubation for 3 hours with MAL
cream (160 mg/g) in UV-exposed (n=19) and non-UV-exposed (n=21) hairless mice.
RESULTS:
Without pretreatment, PpIX fluorescence is higher in UV-exposed skin (P<0.01)
PpIX fluorescence increased (~ 61%) with calcipotriol pretreatment in both UV-exposed mice and nonUV-exposed mice (p<0.01).
With calcipotriol pretreatment, PpIX fluorescence is similar in UV- and non-UV-exposed mice.
CONCLUSION:
Calcipotriol enhances MAL-induced PpIX fluorescence in both UV-exposed and non-UV-exposed skin in
this normal skin murine model.
1 4 TH ANNUAL CONGRESS
Fx Laser + Daylight-PDT vs Daylight-PDT
vs c-PDT vs laser alone in OTR.
Katrine Togsverd-Bo, Copenhagen, Denmark
METHODS:
16 OTR with 542 grade I-III AK in field-cancerized skin (scalp, chest, extremities).
For each patient, after application of sunscreen and curettage, 4 symmetrical
skin areas were randomized to:
- Conventional PDT (cPDT): 3 hours incubation followed by by red light irradiation at 37 J/cm²
- Daylight PDT (DL-PDT): MAL incubated 2½ hours without occlusion
- Ablative fractional laser resurfacing (AFL) alone: 2,940 nm Er:YAG laser at 2.3 mJ/pulse,
1.15W, two stacks, 50
microsecond pulse-duration, 2.4% density
- AFL-DL-PDT
cPDT
DL-PDT
AFL
AFL-DL-PDT
p value
Lesion CR at 3
months (%)
50
46
5
74
<.001
Mean
maximum
pain score
4.5
0.1
0.6
0.22
<.001
1 4 TH ANNUAL CONGRESS
Fx Laser + Daylight-PDT vs Daylight-PDT
vs c-PDT vs laser alone in OTR.
Katrine Togsverd-Bo, Copenhagen, Denmark
RESULTS:
At 3 months, AFL-DL-PDT induced higher efficacy: 74% lesion CR compared to
DL-PDT (46%), cPDT (50%) and AFL (5%) for all grades of AK (p<0.001).
Mean maximal pain scores during AFL-dPDT (0.22), DL-PDT (0.1) and AFL (0.6)
were significantly lower compared to cPDT (4.5) (p<0.001).
Erythema and crusting were more intense in AFL-DL-PDT than DL-PDT and cPDT
(p<0.01)
No pigmentary changes or scar formation at 3 months follow-up
CONCLUSIONS:
AFL-DL-PDT enhances efficacy with excellent tolerability in difficult-to-treat AK
in OTR.
1 4 TH ANNUAL CONGRESS
Conventional MAL-PDT with microneedling
on actinically damaged skin.
Luis Torezan, Sao Paulo, Brazil
METHODS:
Split-face study: 10 patients with symmetrically distributed AKs and photodamage were randomized:
- conventional MAL-PDT (Metvix®, Galderma, Brazil) with previous gentle curettage
- MAL-PDT combined with 1.5 mm high microneedling (Dermaroller®) after MAL application (MN-PDT).
After 90 min of incubation, patients were illuminated with red LED light (635 nm, 37 J/cm²).
RESULTS:
Average AK clearance was 88.3%, with no difference between the sides.
At day 30, global scores for photodamage, mottled pigmentation, roughness, and sallowness improved
on both sides (p < .05), but fine lines improved only on the MN-PDT side (p = .004).
At day 90, facial erythema (p = .04) and coarse wrinkles (p = .002) also improved on the MN-PDT side,
in addition to fine lines for conventional MAL-PDT (p = .01).
Erythema (p = .009), edema (p = .01), crusting (p = .01) and pain(p = .004) were more common and
intense on the MN-PDT side. One patient developed a secondary bacterial infection at day 7 on the
MN-PDT side.
CONCLUSION:
Microneedling-assisted PDT is a safe and effective method and can produce superior cosmetic results
to conventional MAL-PDT for improving photodamaged skin.
1 4 TH ANNUAL CONGRESS
Euro PDT 2014 highlights
Pre-treatment
•
•
•
•
Influence of pre-treatment on face and scalp AK on efficacy and tolerability. Patrick Gholam, Heidelberg, Germany
Pretreatment with calcipotriol enhances MAL-induced PpIX formation. A murine study. Christiane Bay, Copenhagen, Denmark
Fx Laser + Daylight-PDT vs Daylight-PDT vs c-PDT vs laser alone in OTR. Katrine Togsverd-Bo, Copenhagen, Denmark
Conventional MAL-PDT with microneedling on actinically damaged skin. Luis Torezan, Sao Paulo, Brazil
New approaches for PDT
• Results of 2 randomised, controlled, phase III studies with Daylight-PDT in Australia and Europe. Jean-Philippe Lacour, Nice, France
• A new approach to a gentle PDT treatment. Stine Regin Wiegell, Copenhagen, Denmark
• Pulse PDT: A promising new way to reduce inflammation in PDT without reducing efficacy. Hans Christian Wulf, Copenhagen, Denmark
From oncology to antimicrobial PDT
• DEBATE: PDT in sBCC Studies results => when choosing PDT for sBCC. Rianne M.J.P. Gerritsen, Njimegen, The Netherlands & Nicole KellenersSmeets, Maastricht, The Netherlands
• Patch-PDT: convenient and effective for actinic cheilitis? Sonja Radakovic, Vienna, Austria
• PDT field treatment vs. lesion treatment in AK. Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
• MAL-PDT vs Imiquimod 5% cream for skin cancer prevention. Elena Sotirou, Thessaloniki, Greece
• MAL-PDT for mycosis fungoides: a prospective open study and review of literature . Gaelle Quéreux, Nantes, France
• Antimicrobial PDT in chronic leg and foot ulcers. Stan Brown, Leeds, UK
• Clinical and microbiological healing of onychomycosis after 3 sessions of conventional MAL-PDT vs placebo. Yolanda Gilaberte, Huesca, Spain
Abbreviations
1 4 TH ANNUAL CONGRESS
Results of 2 randomised, controlled, phase III
studies with Daylight-PDT in Australia and Europe
Jean-Philippe Lacour, Nice, France
OBJECTIVES:
Evaluate efficacy and safety of daylight MAL PDT (DL-PDT) with 2-hour exposure outside during continuous formation of
PpIX, compared to conventional MAL-PDT (c-PDT) with LED lamps in treating facial/scalp AK.
METHODS:
Randomized, controlled, investigator-blinded, intra-individual non-inferiority multicentric studies
subjects with ≥ 5 symmetrically distributed facial/scalp AK, treated with DL-PDT on one side vs c-PDT on the other side.
Australian study
N=100
European study
N=108
Gender
Male
75%
91.7%
Age
Mean
66.9
72.8
I
56%
9.3%
II
33%
63.9%
III
11%
22.2%
Mean AK per side
14
8.9
Face (vs scalp)
75%
51.3%
Grade I %
97%
58%
Skin phototype
AK characteristics
1 4 TH ANNUAL CONGRESS
Results of 2 randomised, controlled, phase III
studies with Daylight-PDT in Australia and Europe
Jean-Philippe Lacour, Nice, France
Australian study
European study
N=90 per protocole
Mild AK
N=96 per protocole
Mild and moderate AK
DL-PDT
cPDT
P value
DL-PDT
cPDT
P value
Lesion CR at week 12 (%)
89
93
NS
70.1
73.6
NS
Mean pain score
0.8
5.7
<.001
0.7
4.4
<0.001
Related adverse events (%)
39
59
49.6
61.1
RESULTS (preliminary for European study):
DL-PDT was non-inferior to cPDT in terms of complete lesions response rate at week 12 in both study.
In the Australian study, no relationship between efficacy & weather or light dose
In the Australian study, with DL-PDT, most lesions in complete response at Week 12 remained cleared at 6
months : 97% for mild AK, 93% for moderate AK:
DL-PDT was significantly less painful than c-PDT on a VAS scale (0-10):
Daylight-PDT was well tolerated
CONCLUSION:
DL-PDT can be considered an effective, safe and convenient alternative for treatment of facial/scalp AK.
1 4 TH ANNUAL CONGRESS
A new approach to a gentle PDT treatment
Stine Regin Wiegell, Copenhagen, Denmark
OBJECTIVE:
Evaluate if topical corticosteroid would reduce post-PDT erythema after treatment of multiple AK.
METHODS:
Randomized split-face study
21 patients with multiple symmetrically distributed face and scalp AK (mean=13.7 AK/treated area)
MAL-PDT with potent corticosteroid (0.05% clobetasol propionate) before and after PDT on one side
RESULTS:
Potent topical corticosteroid significantly reduced PDT-induced erythema at 24h (p=0.012)
No difference in complete lesion response at 3 months (mean 84%)
No difference in PpIX fluorescence prior to illumination
No correlation between lesion response rate and increased erythema or PpIX fluorescence
Positive correlation between PpIX fluorescence and increased erythema 24h in MAL-PDT areas (same
tendency on the corticosteroid side)
CONCLUSION:
Topical corticosteroid may be an easy way to make PDT treatment of large visible areas more acceptable
1 4 TH ANNUAL CONGRESS
Pulse PDT: A promising new way to reduce
inflammation in PDT without reducing efficacy
Hans Christian Wulf, Copenhagen, Denmark
PULSE PDT FOR AK:
New PDT procedure with the aim to keep most PpIX within the affected cells to destroy these by
apoptosis, and to avoid extracellular leakage...
Pulse PDT for AK procedure: MAL application time of only 30 minutes is used, giving a pulse of MAL,
while illumination is still performed after 3 hours.
SPLIT FACE STUDY: 22 patients with symmetrically distributed face and scalp AK:
Conventional PDT on one side
Pulse PDT on the other side
RESULTS on the pulse PDT side (compared to conventional PDT side):
PpIX fluorescence before illumination significantly lower (p= 0.0001)
Erythema at 24h significantly reduced (p=0.022)
Same maximum pain score during illumination (7.0 vs 7.5)
Same complete lesion response at 3 months (81.7% vs 83.3%)
CONCLUSION:
Can be combined with corticosteroid.
Studies on daylight-Pulse-PDT are needed to make PDT painless and with minimal inflammation
1 4 TH ANNUAL CONGRESS
Euro PDT 2014 highlights
Pre-treatment
•
•
•
•
Influence of pre-treatment on face and scalp AK on efficacy and tolerability. Patrick Gholam, Heidelberg, Germany
Pretreatment with calcipotriol enhances MAL-induced PpIX formation. A murine study. Christiane Bay, Copenhagen, Denmark
Fx Laser + Daylight-PDT vs Daylight-PDT vs c-PDT vs laser alone in OTR. Katrine Togsverd-Bo, Copenhagen, Denmark
Conventional MAL-PDT with microneedling on actinically damaged skin. Luis Torezan, Sao Paulo, Brazil
Enhancing PDT tolerance
• Results of 2 randomised, controlled, phase III studies with Daylight-PDT in Australia and Europe. Jean-Philippe Lacour, Nice, France
• A new approach to a gentle PDT treatment. Stine Regin Wiegell, Copenhagen, Denmark
• Pulse PDT: A promising new way to reduce inflammation in PDT without reducing efficacy. Hans Christian Wulf, Copenhagen, Denmark
From oncology to antimicrobial PDT
• DEBATE: PDT in sBCC Studies results => when choosing PDT for sBCC. Rianne M.J.P. Gerritsen, Njimegen, The Netherlands & Nicole KellenersSmeets, Maastricht, The Netherlands
• Patch-PDT: convenient and effective for actinic cheilitis? Sonja Radakovic, Vienna, Austria
• PDT field treatment vs. lesion treatment in AK. Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
• MAL-PDT vs Imiquimod 5% cream for skin cancer prevention. Elena Sotirou, Thessaloniki, Greece
• MAL-PDT for mycosis fungoides: a prospective open study and review of literature . Gaelle Quéreux, Nantes, France
• Antimicrobial PDT in chronic leg and foot ulcers. Stan Brown, Leeds, UK
• Clinical and microbiological healing of onychomycosis after 3 sessions of conventional MAL-PDT vs placebo. Yolanda Gilaberte, Huesca, Spain
Abbreviations
1 4 TH ANNUAL CONGRESS
DEBATE: PDT in sBCC Studies results
When choosing PDT for sBCC
Rianne M.J.P. Gerritsen, Njimegen, The Netherlands
Nicole Kelleners-Smeets, Maastricht, The Netherlands
PDT for sBCC is most appropriate in patients:
Who want an excellent cosmetic outcome
Who have bad experiences with other treatments
Who don’t want serious adverse events
With multiple tumours
Who choose PDT themselves
With contra-indications for surgery
Optimization of PDT procedure for BCC requires a careful selection of the lesions…
For BCC, Lower response with PDT might be expected:
If tumour depth is superior to 1 mm
In case of location on the limbs
With the following pathological characteristics: nodular and infiltrative types, as well as
ulceration
Fantini et al. EADV 2011
1 4 TH ANNUAL CONGRESS
Patch-PDT: convenient and effective for
actinic cheilitis ?
Sonja Radakovic. Vienna, Austria
METHOD:
Pilot study: 10 patients (9 women, 1 man) including 5 with histologically confirmed actinic cheilitis
2 patients: 1 Alacare®-PDT session, 8 patients: 2 Alacare®-PDT sessions (2 weeks apart)
Pain reduction: diclofenac (n=1), local anesthesia (n=3)
RESULTS:
Overall complete lesion response : 9/12 (75)%:
At 1 month (n=3): CR 1, PR 2
At 2 months (n=3): CR 2, PR 1
At 3 months (n=6): CR 6
Excellent cosmetic outcome
Adverse events:
Phototoxic reaction: minimal (2 patients), moderate (5 patients), strong (4 patients)
Pain was mostly moderate: no treatment interruption
Herpes simplex infection: 4/10 patients
CONCLUSION:
Alacare®-PDT: promising approach for actinic cheilitis.
1 4 TH ANNUAL CONGRESS
PDT field treatment vs lesion treatment in AK
Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
HYPOTHESIS:
If PDT treatment targets an area of field change, it may reduce the risk of development of further new tumors and recurrence.
STUDY DESIGN:
Single centre, prospective, randomized, split face, investigator blind study, in 20 patients with at least 5 up to 10, grade I or II, AK
lesions, symmetrically distributed on two 50 cm² contra-lateral areas, on the face or scalp. One side was treated with ‘lesion to
lesion’ MAL-PDT; the other with ‘field’ MAL-PDT
Lesion treatment
P value
Field treatment
Mean number of AK at baseline
8.6
8.95
.221
Percentage of grade I AK at baseline
89.5
86.6
.809
At M3 (n=20)
81.1
80.8
.669
At M6 (n=15)
75.3
76.1
.814
At M9 (n=16)
84.3
76.6
.009
At M3
16
7
.257
At M6
11
13
.493
At M9
20
10
.014
At M3 (n=20)
1.7
1.7
.717
At M6 (n=15)
2.1
2.1
At M9 (n=16)
1.4
2.1
Lesion CR at 3 months
Number of new lesions
(n=16)
Mean number of
remaining AK
.013
1 4 TH ANNUAL CONGRESS
PDT field treatment vs lesion treatment in AK
Rianne M.J.P. Gerritsen, Nijmegen, The Netherlands
RESULTS:
Baseline characteristics comparable in both treatment areas: mean AK was 8.6 (lesion) vs 8.95 (field), mostly
grade I AK (89.5 vs 86.6%).
Significant lesion reduction (p=.000) in both lesion and field treatment areas at M3, M6 and M9
At M3 and M6, no significant differences between both treatment protocols were found with respect to lesion
reduction or number of new lesions.
At M9, the number of remaining AK was significantly lower in ‘the lesion to lesion’ treated area (1.4 vs 2.1, p =
.013), whereas the number of new lesions was significantly lower in the ‘field’ side (10 vs 20, p=.014).
DISCUSSION:
Treating a mean of 8-9 AK in a field of 50 cm² approaches a field treatment.
When performing a field treatment, extra attention should be paid to the visible lesions.
1 4 TH ANNUAL CONGRESS
MAL-PDT vs Imiquimod 5% cream for skin
cancer
prevention
Elena Sotirou, Thessaloniki, Greece
OBJECTIVES:
To compare efficacy and safety of MAL- PDT versus Imiquimod (IMIQ) 5% in the prevention of new
NMSC in immunocompetent patients with field changes.
METHODS:
Prospective study with intra individual comparison. 44 patients with face or scalp 50cm² field
cancerization areas were randomized to receive MAL-PDT (2 sessions one week apart) on one side,
and IMIQ 5% (3 days a week: 4 weeks on-2 weeks off-4 weeks on) on the mirror field.
RESULTS:
At any time point, number of new lesions didn’t statistically differ. For instance at 12 months: 16 for
PDT vs 22 for IMIQ.
A time-related gradual decline of the prophylactic effect of both treatments was observed.
Both treatments were well tolerated but adverse events were more intense at the fields treated
with IMIQ (topical treatment demanded in 27% in the IMIQ group vs 0% in PDT group).
Patients’ preference favored MAL-PDT (59% vs 41%)
Cosmetic outcome was good/excellent without statistically significant difference
CONCLUSIONS:
MAL-PDT and IMIQ 5% equally prevent development of new AKs in patients with field changes.
MAL-PDT appears to be superior in terms of patients’ preference.
1 4 TH ANNUAL CONGRESS
MAL-PDT for mycosis fungoides: a prospective
open study and review of literature
Gaelle Quéreux, Nantes, France
OBJECTIVE:
To assess PDT effectiveness and tolerability in early-stage MF (stage IA or IB).
METHOD:
Prospective study with 12 patients with 29 histologically proven stage IA or IB MF (maximum 5 lesions per patient).
MAL-PDT sessions were repeated monthly for 6 months.
RESULTS:
Assessment 1month after the 6th session: Objective response in target lesions in 75% of patients (6 CR, 3PR).
Response rates similar between plaques and patches but higher in sun protected (83%) compared to sun-exposed areas (33%)
(trend without reaching significance; p=0.058).
New lesions appeared in 5/12 patients in untreated areas.
Adverse events were localized at the MAL-PDT application sites (grade 1 or 2). Pain score during illumination ranged from 0.5 to
7 (mean 4.5). Most patients were highly satisfied and preferred PDT to the topical chemotherapy previously used.
CONCLUSION:
Large prospective study, PDT appears as a reproducible procedure, effective and appreciated for early-stage MF
Quéreux G et al. J Am Acad Dermatol 2013
1 4 TH ANNUAL CONGRESS
Antimicrobial PDT in chronic leg and foot ulcers
Stan Brown, Leeds, UK
OBJECTIVE:
Aim to develop special, novel photosensitisers PPA904 (Phenothiazinium family) and
protocols to achieve broad-spectrum, antimicrobial action
PHASE II:
RCT single dose study in leg ulcer/diabetic foot ulcer: PPA904 vs placebo.
32 patients with chronic wounds: 16 leg ulcers and 16 diabetic foot ulcers
RESULTS:
In PPA904 treated groups, bacterial counts (including MRSA) were significantly lower
immediately post PDT compared with before PDT.
Approximative reduction = 1 log (p < 0.001).
No significant bacterial reduction in the corresponding placebo groups
Treatment deemed safe and pain-free
Chronic leg ulcers: After 3 months, 4/8 healed on PPA904, 1/8 on placebo.
Morley et al. Br J Dermatol. 2012
1 4 TH ANNUAL CONGRESS
Antimicrobial PDT in chronic leg and foot ulcers
Stan Brown, Leeds, UK
PHASE II:
RCT repeat dose study in leg ulcers
57 patients with chronic (> 3 months) leg ulcers bacterially colonised with >104 cfu/mL:
9 subjects in Part 1 – to assess safety of new formulation / parameters
48 subjects in Part 2 – PPA904 vs placebo
All subjects received up to 12 weekly treatments: PPA904 or placebo gel applied for 15
mins followed by illumination with red light (680nm, 100J/cm²)
RESULTS:
Greater bacterial load reduction with PPA904, compared to placebo (p<0.0001)
Bacterial load returns towards starting point after 1 week
Non-significant trend towards healing compared to placebo (wounds healed: 7 (29.2%)
With PPA904 vs 5 (20.8%) with placebo)
CONCLUSION:
PPA904-PDT can reduce bacterial load, and potentially lead to improved wound healing.
1 4 TH ANNUAL CONGRESS
Clinical and microbiological healing of onychomycosis after
3 sessions of conventional MAL-PDT vs placebo
Yolanda Gilaberte, Huesca, Spain
OBJECTIVE:
To assess efficacy and safety of MAL-PDT for the treatment of onychomycosis
METHOD:
Multicentre, randomized, placebo-controlled clinical trial comparing 3 sessions (1 week apart) of
conventional MAL-PDT with placebo-PDT in both clinically and microbiologically diagnosed onychomycosis
(If conventional antifungals not effective, contraindicated or denied by the patient). Nail plates were
softened 12 hours with 40% ointment urea before treatment.
FIRST IMPRESSIONS ON RESULTS (end of study July 2014):
60 patients have been included.
MAL-PDT seems to work better than red light
MAL-PDT seems to work better than classical antifungal for non-dermatophyte molds
Culture became negative, after the second treatment in most of the cases
Treatment failures with dermatophytes could be associated with multiple nails infection and presence of
tinea pedis during the follow-up
CONCLUSION:
In onychomycosis caused by dermatophytes combination of MAL-PDT for the nail and topical antifungal for
the foot may prevent failures and recurrences.
1 4 TH ANNUAL CONGRESS
Abbreviations
AK
BCC
C-PDT
CR
DL-PDT
LED
MAL
MF
MRSA
NMSC
NS
OTR
PDT
PpIX
PR
SD
Actinic Keratosis
Basal Cell Carcinoma (s=superficial; n=nodular)
Conventional PDT
Complete Response
Daylight mediated PDT
Light-Emitting Diode
Methyl aminolevulinate
Mycosis fungoides
Methicillin-resistant Staphylococcus aureus
Non-Melanoma Skin Cancer
Not significant
Organ Transplant Recipient
Photodynamic Therapy
Protoporphyrin IX
Partial response
Standard deviation

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