Sunscreen PersistenceNCT04618536

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

A study testing Inorganic sunscreen and Organic sunscreen in people with Sunscreen Persistence, run by Shannaz Nadia Yusharyahya at 1 site in Indonesia.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record

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Trial summary

Who is it for?: Ages 18 to 40 yearsHealthy volunteers can take part
Conditions the study is for: Sunscreen Persistence
What is being tested?: Inorganic sunscreen and Organic sunscreen
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 22 participants
Where: 1 siteIndonesia
Study dates: 5 Oct 2020to 31 Jan 2021
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 40 years
All sexes
Healthy volunteers accepted
Adult

Who may be able to join

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.

Who cannot join

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.

Trial locations and contacts

1 site in 1 country.

Indonesia1 site

Cipto Mangunkusumo Hospital
Jakarta, DKI Jakarta, 10430

Other trials in Indonesia

About this study

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
Being tested: Inorganic sunscreen, Organic sunscreen

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Inorganic sunscreenOther
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 sunscreenOther
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.

Study groups in NCT04618536
Study group	Role	What they receive
Inorganic sunscreen	Experimental	Not described Receives: Other: Organic sunscreen
Organic sunscreen	Experimental	Not described Receives: Other: Inorganic sunscreen

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 24 hours

Secondary outcomes (2)

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.
Measured: 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.
Measured: 24 hours

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Oct 202031 Jan 2021

First posted6 Nov 2020
Study start5 Oct 2020
Primary completion5 Dec 2020 (estimated)
Study completion31 Jan 2021 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for Sunscreen PersistenceStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind
Who is masked: Participant, Investigator
Enrolment: 22 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04618536
Sponsor's protocol ID: 20-09-1037
Status last verified: Nov 2020
First submitted: 1 Nov 2020
Last updated: 24 Nov 2020
Results posted: No
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Publications

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.
PubMed 37632909
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.
PubMed 36542453

Study at a glance

From the registry record, last updated by the sponsor on 24 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Comparison of Sun Protection Factor 30 Persistence Between Inorganic and Organic Sunscreen in Swimmer
ClinicalTrials.gov ID: NCT04618536
Acronym / sponsor ID: 20-09-1037
Conditions: Sunscreen Persistence
Study type: Interventional
Recruitment status: Unknown status
Enrolment: 22 participants (estimated)
Lead sponsor: Shannaz Nadia YusharyahyaUniversity, hospital or other
Study start: 5 Oct 2020 (actual)
Primary completion: 5 Dec 2020 (estimated)
Study completion: 31 Jan 2021 (estimated)
First posted: 6 Nov 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Double blind (participant, investigator)
Number of arms: 2

Arm	Type	Receives
Inorganic sunscreen	Experimental	Other: Organic sunscreen
Organic sunscreen	Experimental	Other: Inorganic sunscreen

Who may qualify

Ages: 18 to 40 years
Sex: All
Healthy volunteers: Accepted
Age groups: Adult

Key inclusion criteria (5 listed)

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.

Key exclusion criteria (7 listed)

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.

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Inorganic sunscreenInorganic 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.	Other	Organic sunscreen
Organic sunscreenOrganic 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.	Other	Inorganic sunscreen

Primary outcome

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.

2 secondary outcomes

Inorganic sunscreen SPF
Time frame: 24 hours
Organic sunscreen SPF
Time frame: 24 hours

Results and safety

Results are not available in the source record.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2020.
Derived from this study: PubMed 37632909Rachmani 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.
Derived from this study: PubMed 36542453Rachmani 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.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Karin Rachmani, MD principal investigator

Universitas Indonesia

Shannaz N Yusharyahya, MD, PhD principal investigator

Universitas Indonesia

Adhimukti T Sampurna, MD principal investigator

Universitas Indonesia

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Inorganic sunscreen and Organic sunscreen in people with Sunscreen Persistence, run by Shannaz Nadia Yusharyahya at 1 site in Indonesia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 24 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

SPF change after swimming for 1.5 hours (time frame: 24 hours). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04618536, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Nov 2020.