males or females whose age are at least 18 years subjects who developed papulopustular eruption after EGFRIs initiation Papaulopustular eruption severity of grade 1 2a or 2b (Revised grading system papulopustular eruption epidermal growth factor receptor inhibitors pulse-
Conditions
Interventions
pulse-
dyed laser (585 nanometer wavelength) Vbeam perfecta® by Syneron Medical Ltd.
-
parameter: spot size of 10 mm,
pulse width of 6 ms,
fluence of 7.5 J/cm2 (Fitzpatrick skin type III) or 7 J/cm2 (Fitzpatrick skin type IV)
-
overlapping: 20-
30%
-
number of pass: 1 pass on half-
face treated with pulse-
dyed laser
-
end point: mild erythema
pulse-
dyed laser (PDL) on half-
face area every 2 week,
for 4 sessions
,cryogen (sham control) on half-
for 4 sessions
Adjunctive pulse-
dyded laser,Cryogen (Sham laser)
Sponsors
Quality Improvement Fund, King Chulalongkorn Memorial Hospital
Stiefel laboratory,
GlaxoSmithKline Company
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: 1. Males or females whose age are at least 18 years 2. Subjects who developed papulopustular eruption after EGFRIs initiation 3. Papaulopustular eruption severity of grade 1 2a or 2b (revised grading system based on National Cancer Institute Common Toxicity Criteria version 3) 4. Subjects who take EGFRIs throughout the research 5. Subjects who are able to avoid from sunlight exposure 6. Subjects who have signed consent form
Exclusion criteria
Exclusion criteria: 1. Males or females whose age are less than 18 years 2. Subjects who are currently pregnant or expecting 3. Subjects who are currently breastfeeding 4. Subjects who have done chemical peeling, lasers or IPL on the area of research interest (face) within the past 3 months before the enrollment 5. Subjects who have history of skin condition such as active skin diseases, skin infection on the area of research interest, which might affect either the treatment or the outcome evaluation. 6. Subjects who have history of skin cancers on the area of research interest 7. Subjects who have history of photosensitivity 8. Subjects who have history of abnormal bleeding or coagulation 9. Subjects who have history of delayed wound healing or abnormal scar formation on the area which might affect either the treatment or the outcome evaluation. 10. Subjects who have condition which might affect data collection and outcome evaluation or poses a potential risk to the subjects themselves. (Assessment by investigators or specialized physicians) 11. Subjects who are not qualified or unwilling to abide by the recruitment criteria 12. Subjects who are currently participating in other clinical interventions or using an unapproved or developing medical equipments/devices.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| erythema index Day 0, Day 14, Day 28, Day 42, Day 56, Day 70 skin colorimeter on the reference points by DSM II ColoriMeter® (Cortex technology) | — |
Secondary
| Measure | Time frame |
|---|---|
| papulopustular lesion count Day 0, Day 14, Day 28, Day 42, Day 56, Day 70 counting based on visual inspection and palpation,Severity grading by The Modified NCI Common Terminology Criteria for Adverse Events v4.03 (mCTCAE) Day 0, Day 14, Day 28, Day 42, Day 56, Day 70 The Modified NCI Common Terminology Criteria for Adverse Events v4.03 (mCTCAE) score,Severity grading by revised grading system based on NCI Common Toxicity Criter Day 0, Day 14, Day 28, Day 42, Day 56, Day 70 revised grading system based on National Cancer Institute Common Toxicity Criteria version 3 ,Physical global assessment scores Day 70 photograph assessment by two blinded physicians on quartile rating scale,Patient’s satisfaction Day 70 questionnaire on quartile rating scale,side effect and pain Day 0, Day 14, Day 28, Day 42 visual pain analog scales | — |
Countries
Thailand
Contacts
Public ContactPawinee Rerknimitr
Division of Dermatology, Department of Internal Medicine, Faculty of Medicine Chulalongkorn Universi
Outcome results
None listed