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

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.

Study Overview

• Status: Unknown
• Conditions: Sunscreen Persistence
• Intervention / Treatment: Other: Organic sunscreen; Other: Inorganic sunscreen

• Study Type: Interventional
• Enrollment (Anticipated): 22
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Indonesia
  • DKI Jakarta
    • Jakarta, DKI Jakarta, Indonesia, 10430
      • Cipto Mangunkusumo hospital

Participation Criteria

Eligibility Criteria

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

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Collaborators and Investigators

• Sponsor: 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

Study record dates

Study Major Dates

• Study Start (Actual): October 5, 2020
• Primary Completion (Anticipated): December 5, 2020
• Study Completion (Anticipated): January 31, 2021

Study Registration Dates

• First Submitted: November 1, 2020
• First Submitted That Met QC Criteria: November 1, 2020
• First Posted (Actual): November 6, 2020

Study Record Updates

• Last Update Posted (Actual): November 24, 2020
• Last Update Submitted That Met QC Criteria: November 21, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Dermatologic Agents; Radiation-Protective Agents; Sunscreening Agents
• Other Study ID Numbers: 20-09-1037

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No