Sunscreen AgentsNCT05004168
Sun Protection Factor (SPF) / UVA Protection Factor Study
A study testing Day Gel-0120 and P5 Reference Standard (SPF 35 reference) in people with Sunscreen Agents, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Sunscreen Agents
- What is being tested?
- Day Gel-0120 and P5 Reference Standard (SPF 35 reference)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteIndonesia
- Study dates
- 2 Sep 2020to 24 Sep 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy male or female, 18-60 years of age
- Fair skin with skin type II-IV of Fitzpatrick's skin type
- Able to understand and comply to the investigators instruction.
- Able to read, understand and sign up informed consent form.
Who cannot join
- Subject with a history of abnormal response to sunlight or those taking medication which might produce an abnormal response to sunlight
- Subject exhibiting current sun burn, sun tan, uneven skin tone, or visible skin disease which might be confused with a reaction from the test material or which might interfere with evaluation of test results
- Individuals who are under doctor's care
- Female subjects who indicate that they are pregnant or nursing
- Individuals with known hypersensitivity to any sunscreen products
- Individuals accustomed to using tanning beds
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Clinical Research Supporting Unit
Jakarta Pusat, DKI Jakarta, 10430
About this study
Official title: The Efficacy of Sun Protection Factor (SPF) Against UV-B and UV-A of Cosmetic Products
Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A
Read the detailed description
Sunscreen is intended to protect the skin from sun burn but since the amount of protection needed varies among individuals, sunscreen manufactures offer consumers difference levels of protection. These different levels of protection are expressed as a numerical value called the sun protection factor or SPF. The SPF is the ratio between the minimal erythema dose (MED) of sunscreen product of the protected skin and the MED of the unprotected skin. The minimal erythema dose in human skin is defined as the lowest ultraviolet B (UV-B) dose produces the first perceptible unambigous erythema with defined border appearing over most of the field of UVB exposure 16 - 24 hours after UVB exposure.
The UVA protection factor is the ratio between the Minimal Persistent Pigmentation Darkening Dose (MPPDD) of sunscreen product of the protected skin and the MPPDD of the unprotected skin. The threshold response will be taken as an unequivocal pigment darkening with distinct border which persisted for at least 2 hours.
The test products are Day Gel-0120-C and Day Gel-0120-D with active ingredients ethylhexyl methoxycinnamate, Diethylamino hydroxybenzoyl hexyl benzoate
- Conditions
- Sunscreen Agents
- Being tested
- Day Gel-0120, P5 Reference Standard (SPF 35 reference)
- Keywords
- Sun Protection Factor, Sunscreen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Day Gel-0120Other
Two milligrams of test article applied to the test area. The test products are Day Gel-0120C and Day Gel-0120-D. The products are applied together on the test area with
P5 Reference Standard (SPF 35 reference)Other
The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.
| Study group | Role | What they receive |
|---|---|---|
| SPF evaluation | Experimental | Healthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study Receives: Other: Day Gel-0120; Other: P5 Reference Standard (SPF 35 reference) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To measure the SPF Value of the teat product
The mean of SPF value from all the subject
Measured: 2-24 hours post exposure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2021
- Study start2 Sep 2020
- Primary completion24 Sep 2020
- Study completion24 Sep 2020
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 AgentsStudies 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
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Responsible party
- Principal investigator, Prof. dr. Franciscus D. Suyatna, PhD, SpFK, Universitas Indonesia
- Investigators
- Frans Suyatna, Prof, PhD, Principal investigator, Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05004168
- Sponsor's protocol ID
- CRSU.P.SPF_Paragon/02.20/07.03
- Status last verified
- Aug 2021
- First submitted
- 8 Jul 2021
- Last updated
- 13 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.
PubMed 23748556Donglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179
Study at a glance
From the registry record, last updated by the sponsor on 13 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Sun Protection Factor (SPF) Against UV-B and UV-A of Cosmetic Products
- ClinicalTrials.gov ID
- NCT05004168
- Acronym / sponsor ID
- CRSU.P.SPF_Paragon/02.20/07.03
- Conditions
- Sunscreen Agents
- Keywords
- Sun Protection Factor, Sunscreen
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Collaborators
- PT Paragon Technology and Innovation
- Study start
- 2 Sep 2020 (actual)
- Primary completion
- 24 Sep 2020 (actual)
- Study completion
- 24 Sep 2020 (actual)
- First posted
- 13 Aug 2021 (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.
Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A
Detailed description
Sunscreen is intended to protect the skin from sun burn but since the amount of protection needed varies among individuals, sunscreen manufactures offer consumers difference levels of protection. These different levels of protection are expressed as a numerical value called the sun protection factor or SPF. The SPF is the ratio between the minimal erythema dose (MED) of sunscreen product of the protected skin and the MED of the unprotected skin. The minimal erythema dose in human skin is defined as the lowest ultraviolet B (UV-B) dose produces the first perceptible unambigous erythema with defined border appearing over most of the field of UVB exposure 16 - 24 hours after UVB exposure.
The UVA protection factor is the ratio between the Minimal Persistent Pigmentation Darkening Dose (MPPDD) of sunscreen product of the protected skin and the MPPDD of the unprotected skin. The threshold response will be taken as an unequivocal pigment darkening with distinct border which persisted for at least 2 hours.
The test products are Day Gel-0120-C and Day Gel-0120-D with active ingredients ethylhexyl methoxycinnamate, Diethylamino hydroxybenzoyl hexyl benzoate
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SPF evaluation | Experimental | Other: Day Gel-0120, Other: P5 Reference Standard (SPF 35 reference)Healthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Healthy male or female, 18-60 years of age
- Fair skin with skin type II-IV of Fitzpatrick's skin type
- Able to understand and comply to the investigators instruction.
- Able to read, understand and sign up informed consent form.
Key exclusion criteria (6 listed)
- Subject with a history of abnormal response to sunlight or those taking medication which might produce an abnormal response to sunlight
- Subject exhibiting current sun burn, sun tan, uneven skin tone, or visible skin disease which might be confused with a reaction from the test material or which might interfere with evaluation of test results
- Individuals who are under doctor's care
- Female subjects who indicate that they are pregnant or nursing
- Individuals with known hypersensitivity to any sunscreen products
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 |
|---|---|---|
| Day Gel-0120Two milligrams of test article applied to the test area. The test products are Day Gel-0120C and Day Gel-0120-D. The products are applied together on the test area with | Other | SPF evaluation |
| P5 Reference Standard (SPF 35 reference)The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product. | Other | SPF evaluation |
Primary outcome
To measure the SPF Value of the teat product
Time frame: 2-24 hours post exposure
The mean of SPF value from all the subject
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Aug 2021.
- Background: PubMed 23748556Heckman CJ, Chandler R, Kloss JD, Benson A, Rooney D, Munshi T, Darlow SD, Perlis C, Manne SL, Oslin DW. Minimal Erythema Dose (MED) testing. J Vis Exp. 2013 May 28;(75):e50175. doi: 10.3791/50175.
- BackgroundDonglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179
Related trials for Sunscreen Agents
RecruitingPhase 4
A Clinical Study to Evaluate the Efficacy and SPF of Two Test Materials According to an Adaptation of the Guidelines of the FDA Sunscreen Drug Products for Over-the-Counter Human Use
Epidermis, Ultraviolet Exposure
Recruiting
Sun Exposure and Activities After Skin Cancer: Optimization of mHealth Interventions
Melanoma (Skin Cancer)
Enrolling by invitationObservational study
Expert Consensus on Photoprotection Practices: A Delphi Study
Photoprotection, Sunscreen
Recruiting
Evaluation of Efficacy of Anthelios Sunscreen on Face Versus Usual Routine on Signs of Aging
Aging
Active, not recruiting
Impact of Sunscreen Dispensers in Parks Visited by Teenagers
Skin Neoplasm, Adolescent Behavior
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.
Frans Suyatna, Prof, PhD principal investigator
Clinical Research Supporting Unit, Faculty of Medicine, University of 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 Day Gel-0120 and P5 Reference Standard (SPF 35 reference) in people with Sunscreen Agents, run by Universitas Indonesia 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 4 inclusion and 6 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: finished, as of the sponsor's last update on 13 Aug 2021. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
To measure the SPF Value of the teat product (time frame: 2-24 hours post exposure). 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 NCT05004168, 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 13 Aug 2021.