Erythema after sun exposure in healthy volunteers MedDRA version: 14.1 Level: LLT Classification code 10045745 Term: Unspecified dermatitis due to sun System Organ Class: 100000004858
Conditions
Interventions
Product Name: Melatonin
Pharmaceutical Form: Cream
INN or Proposed INN: Melatonin
CAS Number: 73-31-4
Other descriptive name: MELATONIN
Concentration unit: % percent
Concentration type: equal
Concentr
Sponsors
Department of surgery, Herlev Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Healthy volunteers of both sexes. Skintype 1-3 acording to Fitzpatrick skin type scale. No sun exposure on skin area tested in the study 4 weeks prior to the study. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 17 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Active skindisease Pregnancy Previous malignant or pre malignant skin disease
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Primary end point(s): Erythema assessed by digital image analysis (Image J).;Timepoint(s) of evaluation of this end point: Before sun exposure+4,8,24 hours after sun exposure;Main Objective: Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure. ;Secondary Objective: Visual inspection of erythema using Frosch-Klingman scale. Testing for primary hyperalgesi in the sunexposed area with Pin-Prick monofilaments. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): Erythema assessed by visual score (Frosch-Klingman scale) Hyperalgesia assessed by mechanical stimulation with monofilament. ;Timepoint(s) of evaluation of this end point: Before sun exposure+4,8,24 hours after sun exposure. | — |
Countries
Denmark, Turkey
Contacts
Public ContactIsmail Gögenur
Department of Surgery, Herlev Hospital
Outcome results
None listed