Sun Protection Factor (SPF) / UVA Protection Factor Study
The Efficacy of Sun Protection Factor (SPF) Against UV-B and UV-A of Cosmetic Products
1 other identifier
interventional
20
1 country
1
Brief Summary
Evaluation of the effectiveness of sunscreen products by determining its Sun Protection Factor (SPF) against UV-B and UV-A
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Sep 2020
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 2, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 24, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
September 24, 2020
CompletedFirst Submitted
Initial submission to the registry
July 8, 2021
CompletedFirst Posted
Study publicly available on registry
August 13, 2021
CompletedAugust 13, 2021
August 1, 2021
22 days
July 8, 2021
August 11, 2021
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To measure the SPF Value of the teat product
The mean of SPF value from all the subject
2-24 hours post exposure
Study Arms (1)
SPF evaluation
EXPERIMENTALHealthy male or female subjects with Fitzpatrick Skin Type of II-IV were included in the SPF study
Interventions
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
The reference product is P5 according to ISO 24444:2019. The application of reference product is similar with test product.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Indonesia Universitylead
- PT Paragon Technology and Innovationcollaborator
Study Sites (1)
Clinical Research Supporting Unit
Jakarta Pusat, DKI Jakarta, 10430, Indonesia
Related Publications (2)
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.
PMID: 23748556BACKGROUNDDonglikar MM, Deore SL. Sunscreens: A review. Pharmacognosy Journals. 2016;8(3):171-179
BACKGROUND
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Frans Suyatna, Prof, PhD
Clinical Research Supporting Unit, Faculty of Medicine, University of Indonesia
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- PREVENTION
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Clinical Pharmacology Professor
Study Record Dates
First Submitted
July 8, 2021
First Posted
August 13, 2021
Study Start
September 2, 2020
Primary Completion
September 24, 2020
Study Completion
September 24, 2020
Last Updated
August 13, 2021
Record last verified: 2021-08