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

NCT04618536 | Unknown

• 1 other identifier: 20-09-1037
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Sunscreen Persistence

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• Inorganic sunscreen SPF

  24 hours

• Organic sunscreen SPF

  24 hours

Study Arms (2)

Inorganic sunscreen

EXPERIMENTAL

Other: Organic sunscreen

Organic sunscreen

EXPERIMENTAL

Other: Inorganic sunscreen

Interventions

Inorganic sunscreen OTHER

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 OTHER

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.

Inorganic sunscreen

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Shannaz Nadia Yusharyahya: lead

Study Sites (1)

Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, 10430, Indonesia

Location

Related Publications (2)

• Rachmani K, Yusharyahya SN, Sampurna A, Ranakusuma RW, Widaty S. The Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Double-blind Randomized Clinical Trial. JMIR Dermatol. 2023 Jan 4;6:e41633. doi: 10.2196/41633.

  PMID: 37632909 DERIVED

• Rachmani K, Yusharyahya SN, Sampurna A, Ranakusuma RW, Widaty S. Comparison of Sun Protection Factor (SPF) 30 Persistence Between Inorganic and Organic Sunscreen in Swimmers: Protocol for a Multicenter, Randomized, Noninferiority, Split-Body, Double-Blind Clinical Trial. JMIR Res Protoc. 2022 Dec 21;11(12):e42504. doi: 10.2196/42504.

  PMID: 36542453 DERIVED

Study Officials

• 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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Consultant of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia

Study Record Dates

• First Submitted: November 1, 2020
• First Posted: November 6, 2020
• Study Start: October 5, 2020
• Primary Completion: December 5, 2020
• Study Completion: January 31, 2021
• Last Updated: November 24, 2020

Record last verified: 2020-11

Data Sharing

• IPD Sharing: Will not share

Locations

ID (1)