The sun protective effect of melatonin: a study on healthy volunteers.

Phase 1

Conditions: Erythema after sun exposure in healthy volunteers
MedDRA version: 14.1Level: LLTClassification code 10045745Term: Unspecified dermatitis due to sunSystem Organ Class: 100000004858
Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

Registration Number: EUCTR2013-000629-30-DK

Lead Sponsor: Department of surgery, Herlev Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Authorised-recruitment may be ongoing or finished

Sex: All

Target Recruitment: 17

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

Active skindisease
Pregnancy
Previous malignant or pre malignant skin disease

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure.<br>;Secondary Objective: Visual inspection of erythema using Frosch-Klingman scale.<br><br>Testing for primary hyperalgesi in the sunexposed area with Pin-Prick monofilaments.;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

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Erythema assessed by visual score (Frosch-Klingman scale)<br>Hyperalgesia assessed by mechanical stimulation with monofilament.<br><br>;Timepoint(s) of evaluation of this end point: Before sun exposure+4,8,24 hours after sun exposure.