Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer

Sunscreen Persistence Clinical Trial

Official title:

Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer

Clinical Trial Details — Status: Enrolling by invitation

Administrative data

• NCT number: NCT04618536
• Other study ID #: 20-09-1037
• Status: Enrolling by invitation
• Phase: N/A
• Start date: October 5, 2020
• Est. completion date: January 31, 2021

Study information

• Verified date: November 2020
• Source: Indonesia University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Prolonged sunlight exposure in swimming athletes can cause various changes in the skin; among them is sunburn. The use of sunscreen can reduce sunburn effectively. However, various types of physical activity that can trigger sweating, friction, washing with water, or sun exposure after sunscreen use can interfere with its effectiveness in the form of a decreased SPF level. The purpose of this study is to determine and compare the persistence of organic and inorganic sun protection factor 30 (SPF 30) sunscreens after 1.5 hours of swimming.

Recruitment information / eligibility

• Status: Enrolling by invitation
• Enrollment: 22
• Est. completion date: January 31, 2021
• Est. primary completion date: December 5, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Female or male swimming athletes aged 18-40 years.
• Practice swimming at least 3 times a week with a duration of 1.5-2 hours per practice in the morning or afternoon.
• Willing to be the subject of research by signing the consent.
• Do not have skin diseases.
• Do not have a history of allergies to sunscreens.

Exclusion Criteria:

• Existence of skin lesion in the test area.
• In the treatment of phototherapy.
• Using drugs with photosensitivity side effects.
• History of skin malignancy, history of photosensitivity reactions or history of disease affected by UV rays.
• Exposure to direct sunlight to the test area 24 hours before the study and during the study period.
• Absence of erythema response 24 hours after the radiation test.
• Erythema occurs in the entire test area box 24 hours after the radiation test.

Related Conditions & MeSH terms

• Sunscreen Persistence

Intervention

Other:
• Inorganic sunscreen
Inorganic sunscreen will be applied evenly to 2 areas on the back of the subject with a 1 cc syringe and gloved finger in an amount of 2 mg / cm2. In the first session, one area will be irradiated 20 minutes after sunscreen application. In the second session, the other area will be irradiated after the subject has swam for 1.5 hours.
• Organic sunscreen
Organic sunscreen will be applied evenly to 2 areas on the back of the subject with a 1 cc syringe and gloved finger in an amount of 2 mg / cm2. In the first session, one area will be irradiated 20 minutes after sunscreen application. In the second session, the other area will be irradiated after the subject has swam for 1.5 hours.

Locations

Country	Name	City	State
Indonesia	Cipto Mangunkusumo Hospital	Jakarta	DKI Jakarta

Sponsors (1)

Lead Sponsor	Collaborator
Shannaz Nadia Yusharyahya

Country where clinical trial is conducted

Indonesia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	SPF change after swimming for 1.5 hours	SPF of inorganic and organic sunscreen were calculated before and after swimming. The difference between SPF before and after swimming will be calculated and compared between the organic and inorganic group. SPF were calculated using minimal erythemal dose (MED) test. The test itself will be conducted in 2 days. Irradiation will be conducted on the first day and minimal erythemal dose result will be collected 24 hours after the irradiation.	24 hours
Secondary	Inorganic sunscreen SPF	SPF resulted from in vivo method, conducted before swimming. SPF were calculated using MED test. The test itself will be conducted in 2 days. Irradiation will be conducted on the first day and MED result will be collected 24 hours after the irradiation.	24 hours
Secondary	Organic sunscreen SPF	SPF resulted from in vivo method, conducted before swimming. SPF were calculated using minimal erythemal dose test. The test itself will be conducted in 2 days. Irradiation will be conducted on the first day and minimal erythemal dose result will be collected 24 hours after the irradiation.	24 hours