MELATOX: Pharmacodynamic evaluation of topical use of melatonin as sun protection: a study on healthy volunteers.

Phase 1

• Conditions: Adverse effects of topical use of melatonin as sun protection.; MedDRA version: 16.0Level: PTClassification code 10060933Term: Adverse eventSystem Organ Class: 10018065 - General disorders and administration site conditions; Therapeutic area: Analytical, Diagnostic and Therapeutic Techniques and Equipment [E] - Therapeutic techniques [E02]

• Registration Number: EUCTR2013-003023-10-DK
• Lead Sponsor: Department of Surgery, Herlev Hospital

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2013-10-07
• Last Update Posted: 10 August 2021

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 10

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

Exclusion Criteria

- Pregnancy
- Active skin disease
- Use of hypnotica or sedativa.
- Known sleeping disorder.
- Known allergy to substances in the cream

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Secondary Objective: - Evaluation of cognitive dysfunction assessed by Finger tapping test and Continous reaction time test.<br>- Transdermal administration of melatonin assessed by analyzing bloodsamples.<br>- Evaluation of melatonin distribution in urine and saliva after topical use of melatonin cream 12,5%.<br>- Evaluation of influence on heart rate, bloodpressure, plus and temperature after topikal administration of melatonin cream 12,5%;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;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 Measures

Name	Time	Method
Secondary end point(s): - Cognitive dysfunction evaluated by Finger tapping test and Continous reaction time test after treatment with melatonin cream 12,5%.<br>- Distribution of transdermal melatonin in blood after treatment with melatonin cream 12,5%.<br>- Distributioin of transdermal melatonin in urine and saliva after treatment with melatonin cream 12,5%.<br>- 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.