Sunburn Clinical Trial
Official title:
The Sun Protective Effect of Melatonin: a Randomized, Placebo-controlled, Double-blind Study on Healthy Volunteers
The aim of this study is to investigate the sun protective effect of melatonin, when used as
a cream applied before sun exposure.
Sun exposure induces erythema as indication of an inflammatory reaction in the skin. It is
proven that the amount of free radicals in the skin are increased by UV exposure.
Furthermore, it is known that melatonin is a potent antioxidant. It is hypothesized that
melatonin can be protective against the UV induced release of free radicals by acting as a
radical scavenger and thereby protect against UV-induced cellular damage.
Status | Completed |
Enrollment | 22 |
Est. completion date | August 2013 |
Est. primary completion date | May 2013 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Both |
Age group | 18 Years to 90 Years |
Eligibility |
Inclusion Criteria: - Healthy volunteers of both sexes. - Skin type 1-3 according to Fitzpatrick skin type scale. - No sun exposure on skin area tested in the study 4 weeks prior to the study. Exclusion Criteria: - Active skin disease - Participant that do not react to the given sun exposure with a change in a-value >5 are excluded from the data. - Pregnancy - Previous malignant or pre malignant skin disease. |
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Prevention
Country | Name | City | State |
---|---|---|---|
Denmark | Gastroenheden, Herlev Hospital | Herlev |
Lead Sponsor | Collaborator |
---|---|
Herlev Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Visual inspection of erythema using Frosch-Klingman scale. | This secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure | No | |
Primary | Reduction of erythema assessed by digital image analysis (Image J) after treatment with melatonin/placebo before sun exposure. | The alpha value measured in a "color space converted" image will represent the degree of erythema | Primary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure | No |
Secondary | Testing for primary hyperalgesia in the sun exposed area with Pin-Prick monofilaments. Testing for primary hyperalgesia in the sun-exposed area with Pin-Prick monofilaments. | The secondary outcome is assessed at: baseline and 1,4,8 and 24 hours post exposure. | No |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT00206882 -
The Sun Protection Effect and Efficacy in Treatment of Sunburn Using Topical Corticosteroids.
|
N/A | |
Completed |
NCT05767008 -
Water Immersion Studies of a Long-wear Sunscreen to Improve Protection Against Ultraviolet Radiation
|
N/A | |
Completed |
NCT00441051 -
Efficacy and Safety of Diclofenac Sodium (0.1%) Gel in Patients With UV Induced Painful Sunburn
|
Phase 3 | |
Completed |
NCT00326274 -
Clinical Safety Trial of Long-Term Intermittent Use of Helioblock® SX Cream
|
Phase 3 | |
Completed |
NCT03199573 -
Hats on Head Start: A A Survey of Sun Protection Behaviors in Head Start and Other Early Childhood Education Programs
|
N/A | |
Terminated |
NCT03332524 -
Clinical Trial of the Safety and Efficacy of SP160412 in the Temporary Relief of Mild to Moderate Sunburn
|
Phase 2 | |
Completed |
NCT03752736 -
Sun Safety Skills for Elementary School Students
|
N/A | |
Completed |
NCT05260359 -
Dermal Irritation, Sensitization and Cumulative Irritation Potential of 6% Bemotrizinol
|
Phase 2 | |
Completed |
NCT01021787 -
Dermal Penetration of the Titanium Dioxide in Anthelios SX SPF40 Cream
|
Phase 4 | |
Completed |
NCT03607578 -
Test of Interventions to Prevent Skin Cancer Among Danes on Vacation in High UV Index Sunny Destinations
|
N/A | |
Completed |
NCT03489356 -
Project Options - The ABC Method
|
N/A | |
Enrolling by invitation |
NCT03007589 -
Natural Sunlight Protection and Simulated Sunlight Protection Offered by Sunscreens and Fabrics
|
N/A | |
Not yet recruiting |
NCT01237925 -
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Gel) in the Relief of Sunburn Related Symptoms
|
Phase 3 | |
Not yet recruiting |
NCT01085851 -
Non-inferiority Clinical Trial of Dexchlorpheniramine (Cream Versus Lotion) in the Relief of Sunburn Related Symptoms
|
Phase 3 |