MELATOX: Pharmacodynamic evaluation of topical use of melatonin as sun protection: a randomized, double blinded, placebo controlled crossover study on healthy volunteers.

INTERVENTION: Product Name: Melatonin Pharmaceutical Form: Cream CAS Number: 73‐31‐4 Other descriptive name: MELATONIN Concentration unit: % percent Concentration type: equal Concentration number: 12,5‐ Pharmaceutical form of the placebo: Cream Route of administration of the placebo: Cutaneous use CONDITION: Adverse effects of topical use of melatonin as sun protection. ; MedDRA version: 16.0 Level: PT Classification code 10060933 Term: Adverse event System Organ Class: 10018065 ‐ General disorders and administration site conditions Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] ‐ Therapeutic techniques [E02] PRIMARY OUTCOME: Main Objective: Evaluation of subjective sleepiness after topikal treatment with cream containing melatonin 12,5% or placebo assessed by scoring with Karolinska Sleepiness Scale. Primary end point(s): Subjective sleepiness assessed by Karolinska Sleepiness Scale Secondary Objective: ‐ Evaluation of cognitive dysfunction assessed by Finger tapping test and Continous reaction time test.; ‐ Transdermal administration of melatonin assessed by analyzing bloodsamples.; ‐ Evaluation of melatonin distribution in urine and saliva after topical use of melatonin cream 12,5%.; ‐ Evaluation of influence on heart rate, bloodpressure, plus and temperature after topikal administration of melatonin cream 12,5% Timepoint(s) of evaluation of this end point: Before treatment+1,2,3,4,5,6,7,8,9,12, 24 and 36 hours after treatment. SECONDARY OUTCOME: Secondary end point(s): ‐ Cognitive dysfunction evaluated by Finger tapping test and Continous reaction time test after treatment with melatonin cream 12,5%.; ‐ Distribution of transdermal melatonin in blood after treatment with melatonin cream 12,5%.; ‐ Distributioin of transdermal melatonin in urine and saliva after treatment with melatonin cream 12,5%.; ‐ Influence of vital heart rate, blood pressure, plus and temperature by topikal treatment with melatonin cream 12,5%. Timepoint(s) of evaluation of this end point: Before treatment+1,2,3,4,5,6,7,8,12, 24 and 36 hours after treatment. INCLUSION CRITERIA: ‐ Healthy volunteers of both sexes. ‐ No shiftwork ‐ No ingestion of caffeine containing food or beverages 24 hours before and under the study session. ‐ Pittsburgh sleep quality index score <5 ‐ Hight 165‐190 cm. ‐ Weight 53‐85 kg. 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 10 F.1.3 Elderly (>=65 years) no F.1.3.1 Number of subjects for this age range