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

• ClinicalTrials.gov Identifier: NCT04618536
• Recruitment Status: Enrolling by invitation
• First Posted: November 6, 2020
• Last Update Posted: November 24, 2020
• Sponsor: Shannaz Nadia Yusharyahya
• Information provided by (Responsible Party): Shannaz Nadia Yusharyahya, Indonesia University

Study Description

Brief 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.

Condition or disease	Intervention/treatment	Phase
Sunscreen Persistence	Other: Inorganic sunscreen; Other: Organic sunscreen	Not Applicable

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 22 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Double (Participant, Investigator)
• Primary Purpose: Treatment
• Official Title: Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer
• Actual Study Start Date: October 5, 2020
• Estimated Primary Completion Date: December 5, 2020
• Estimated Study Completion Date: January 31, 2021

Arms and Interventions

Arm	Intervention/treatment
Experimental: Inorganic sunscreen	Other: 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.
Experimental: Organic sunscreen	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.

Outcome Measures

Primary Outcome Measures :

1. SPF change after swimming for 1.5 hours [ Time Frame: 24 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.

Secondary Outcome Measures :

1. Inorganic sunscreen SPF [ Time Frame: 24 hours ]
   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.
2. Organic sunscreen SPF [ Time Frame: 24 hours ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 40 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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.

Contacts and Locations

Locations

Indonesia

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia, 10430

Sponsors and Collaborators

Shannaz Nadia Yusharyahya

Investigators

• Principal Investigator: Karin Rachmani, MD; Indonesia University
• Principal Investigator: Shannaz N Yusharyahya, MD, PhD; Indonesia University
• Principal Investigator: Adhimukti T Sampurna, MD; Indonesia University
• Principal Investigator: Respati W Ranakusuma, MD, PhD; Indonesia University
• Principal Investigator: Sandra Widaty, MD, PhD; Indonesia University

More Information

• Responsible Party: Shannaz Nadia Yusharyahya, Consultant of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, Indonesia University
• ClinicalTrials.gov Identifier: NCT04618536
• Other Study ID Numbers: 20-09-1037
• First Posted: November 6, 2020
• Last Update Posted: November 24, 2020
• Last Verified: November 2020

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:

Sunscreening Agents; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Dermatologic Agents