CClinicalTrials.gg
Status unknownNCT04618536Updated Nov 24, 2020

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

An interventional study of Inorganic sunscreen and Organic sunscreen in Sunscreen Persistence, sponsored by Shannaz Nadia Yusharyahya. Status unknown at 1 site in Indonesia. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-11-24.

Sponsored by Shannaz Nadia Yusharyahya · Not applicable, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Nov 2020), so the status shown — last known as Enrolling by invitation — may be out of date.
Phase
Not applicable
Study type
Interventional
Enrollment
22
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
01

Study 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.

02

Conditions studied

  • Sunscreen Persistence
03

In context

Lead sponsor

Shannaz Nadia Yusharyahya is the lead sponsor of 2 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

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

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.
05

Study design

Phase
Not applicable
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Investigator)
Enrollment
22 participants (estimated)

Study arms

  • Experimental
    Inorganic sunscreen

    Other: Organic sunscreen

  • Experimental
    Organic sunscreen

    Other: Inorganic sunscreen

Interventions

  • OtherInorganic 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.

  • OtherOrganic 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.

06

What researchers measure

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.

    Time frame: 24 hours

Secondary outcomes

  1. 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.

    Time frame: 24 hours

  2. 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.

    Time frame: 24 hours

07

Study locations

1 site
  • Cipto Mangunkusumo Hospital
    Jakarta, DKI Jakarta 10430, Indonesia
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Nov 24, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT04618536
Lead sponsor
Shannaz Nadia Yusharyahya
Responsible party
Shannaz Nadia Yusharyahya (Consultant of Dermatology and Venereology, Faculty of Medicine Universitas Indonesia, Indonesia University) — Sponsor-investigator
First posted
Nov 6, 2020
Start date
Oct 5, 2020
Primary completion
Dec 5, 2020 (estimated)
Completion
Jan 31, 2021 (estimated)
Last update
Nov 24, 2020

Study contacts

Karin Rachmani, MD
principal investigator · Indonesia University
Shannaz N Yusharyahya, MD, PhD
principal investigator · Indonesia University
Adhimukti T Sampurna, MD
principal investigator · Indonesia University
Respati W Ranakusuma, MD, PhD
principal investigator · Indonesia University
Sandra Widaty, MD, PhD
principal investigator · Indonesia University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Nov 2020. You cannot join it, but the record below documents what was studied.

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