- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03157583
A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
May 17, 2019 updated by: GlaxoSmithKline
Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
The purpose of this study is to determine the SPF and UVAPF of four sunscreen formulations using international standard methodologies ISO24444:2010 for SPF and ISO24443:2012 for UVAPF.
Study Overview
Status
Completed
Conditions
Detailed Description
This study consist of two steps.
Step 1: determination of the SPF of the test products which will be performed as a single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study as per ISO24444:2010.
And Step 2: determination of the UVAPF of the test products which will be performed as a single center, open-label, negative and positive controlled technical test as per ISO24443:2012 (using test plates for assessing UV transmittance of four developmental sunscreens).
Study Type
Interventional
Enrollment (Actual)
8
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Schleswig-Holstein
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Schenefeld, Schleswig-Holstein, Germany, 22869
- GSK Investigational Site
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to participate as evidenced by voluntary written informed consent and has received a signed and dated copy of the informed consent form
- Good general and mental health with, in the opinion of the investigator or medically qualified designee no clinically significant and relevant abnormalities in medical history or upon physical examination
- Participants with a Fitzpatrick Skin Type of I, II or III
- Participants with an Individual Typology Angle (ITA°) greater than 28°
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the duration of the study
- Women who are breast-feeding or lactating
- Participants having used medication with known photo-toxic and/or photosensitizing potential (e.g. hypericum perforatum, antibiotics, blood pressure regulating agents) up to 14 days prior to screening
- Participants with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening
- Participants with dermatological conditions
- Participants with a history of abnormal response to the sun
- Participants having marks, blemishes or nevi or presenting existing sun damage in the test area
- Participants having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation
- Participants with a history of systemic therapy with immuno-suppressive drugs (e.g. corticosteroids) and/or antihistamines (e.g. anti-allergics) up to 7 days prior to screening
- Participants with a non-uniform skin colour or hyperpigmentation in the test area
- Participants with a medical history of dysplastic nevi or melanoma
- Participants with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer
- Participants with asthma, unless medicated
- Participants with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation
- AIDS (acquired immune deficiency syndrome) and infectious hepatitis, if known to the participants
- Known or suspected intolerance or hypersensitivity to the study materials (or closely related compounds) or any of their stated ingredients
- Known allergy to latex
- Participation in another clinical study (including cosmetic studies) or receipt of an investigational drug within 30 days prior to screening
- Participation in another clinical study involving UV exposure to the same test site up to 2 months prior to screening
- Previous participation in this study
- Recent history (within the last 5 years) of alcohol or other substance abuse
- Participants who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening
- Participants accustomed to using tanning beds
- Participants who have used self-tanning products on the back area in the previous 1 month prior to screening
- An employee of the sponsor or the study site or members of their immediate family
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Reference product (for SPFi calculation)
This arm will include all the test sites on the participants back where reference product (P3 standard sunscreen) will be applied.
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A total of 2.0 ± 0.05 mg/cm2 reference P3 standard will be spread at the topical test sites on the back of each participant.
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Experimental: Test product 1
This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 1 will be applied for SPF testing.
|
A total of 2.0 ± 0.05 mg/cm2 (milligram per centimeter square of test site area) NGBUV000A (test product 1) will be spread at the topical test sites on the back of each participant.
And a total of 1.3 mg/cm2 of test product 1 will be applied to the test plates.
|
Experimental: Test product 2
This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 2 will be applied for SPF testing.
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A total of 2.0 ± 0.05 mg/cm2 NGBUV000B (test product 2) will be spread at the topical test sites on the back of each participant.
And a total of 1.3 mg/cm2 of test product 2 will be applied to the test plates.
|
Experimental: Test product 3
This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 3 will be applied for SPF testing.
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A total of 2.0 ± 0.05 mg/cm2 NGBUV000C (test product 3) will be spread at the topical test sites on the back of each participant.
And a total of 1.3 mg/cm2 of test product 3 will be applied to the test plates.
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Experimental: Test product 4
This arm will include all the test plates used for UVAPF testing and test sites on the participants back where test product 4 will be applied for SPF testing.
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A total of 2.0 ± 0.05 mg/cm2 NGBUV000D (test product 4) will be spread at the topical test sites on the back of each participant.
And a total of 1.3 mg/cm2 of test product 4 will be applied to the test plates.
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No Intervention: Negative control (for SPFi calculation)
This arm will include all the test sites on the participants back which will be left unprotected.
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Active Comparator: Reference (for UVAPFi calculation)
This arm will include test plates treated with reference sunscreen formulation S2.
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A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
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Other: Blank control (for UVAPFi calculation)
This arm will include blank test plates treated with glycerin.
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A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
Time Frame: Up to 24 hours post UV exposure
|
Arithmetic mean of all valid SPFi values of each product on each participant was calculated from the individual Minimal Erythemal Dose (MED) on product treated (MEDp) test sites in relation to unprotected (MEDu) test sites 16-24 hours after exposure to ultraviolet (UV) radiation.
SPFi = MEDp/MEDu.
No inferential statistical analysis was performed for this outcome.The provisional MEDu was the lowest dose of UV radiation that produces the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure.Higher values represents increased SPF protection.
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Up to 24 hours post UV exposure
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Spectrum of Sun Protection
Time Frame: Up to 30 minutes post UV exposure
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Broad spectrum of sun protection was calculated by the ratio of the arithmetic mean of SPF to the arithmetic mean of UVAPF.
Higher values represents increased SPF protection.
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Up to 30 minutes post UV exposure
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
June 21, 2017
Primary Completion (Actual)
July 7, 2017
Study Completion (Actual)
July 7, 2017
Study Registration Dates
First Submitted
May 16, 2017
First Submitted That Met QC Criteria
May 16, 2017
First Posted (Actual)
May 17, 2017
Study Record Updates
Last Update Posted (Actual)
July 22, 2019
Last Update Submitted That Met QC Criteria
May 17, 2019
Last Verified
May 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 207583
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
No
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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