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

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

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2013-003023-10-DK

Enrollment

Registered

2013-10-07

Start date

2013-10-07

Completion date

Unknown

Last updated

2021-08-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

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- Pharmaceuti

Eligibility

Sex/Gender

All

Inclusion criteria

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 =65 years) no F.1.3.1 Number of subjects for this age range

Exclusion criteria

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

Design outcomes

Primary

Measure	Time frame
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%;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.	—

Measure

Time frame

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%;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.

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Secondary

Measure	Time frame
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.	—

Measure

Time frame

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.

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Countries

Denmark

Contacts

Public ContactIsmail Gögenur

Department of Surgery, Herlev Hospital

ismail.gogenur@regionh.dk004538689501

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026