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

NCT ID: NCT04618536

Last Updated: 2020-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-10-05

Study Completion Date

2021-01-31

Brief Summary

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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.

Detailed Description

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Conditions

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Sunscreen Persistence

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Inorganic sunscreen

Group Type EXPERIMENTAL

Organic sunscreen

Intervention Type 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.

Organic sunscreen

Group Type EXPERIMENTAL

Inorganic sunscreen

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Shannaz Nadia Yusharyahya

OTHER

Sponsor Role lead

Responsible Party

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Shannaz Nadia Yusharyahya

Consultant of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Karin Rachmani, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Shannaz N Yusharyahya, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Adhimukti T Sampurna, MD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Respati W Ranakusuma, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Sandra Widaty, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Indonesia University

Locations

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Cipto Mangunkusumo Hospital

Jakarta, DKI Jakarta, Indonesia

Site Status

Countries

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Indonesia

References

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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.

Reference Type DERIVED
PMID: 37632909 (View on PubMed)

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.

Reference Type DERIVED
PMID: 36542453 (View on PubMed)

Other Identifiers

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20-09-1037

Identifier Type: -

Identifier Source: org_study_id