Determination of the Sun Protection Factor (SPF) of a Cosmetic Daily De-fence Skin Cream

• Sponsor: GlaxoSmithKline (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03136107
• Collaborator: (none)
• Enrollment: 26
• Location: 1
• Arms: 3
• Actual Duration (Months): 1
• Patients Per Site Per Month: 25.5

Study Details

Study Description

Brief Summary

The purpose of this study is to determine the SPF of the test product according to the International Standards Organization (ISO) 24444:2010 methodology (In vivo determination of the SPF).

Condition or Disease	Intervention/Treatment	Phase
Sunscreening Agents	Other: Physiogel Daily Defence Protective Day Cream Light; Other: ISO 24444:2010 P3 Standard Sunscreen	N/A

Detailed Description

A single-center, randomized, evaluator blind, intra-individual comparison, no treatment and positive controlled clinical study to determine the SPF of Physiogel Daily Defence Protective Day Cream Light as per ISO 24444:2010. The provisional minimal erythemal dose of unprotected skin (MEDu) for each subject will be determined before starting the test phase. Once the provisional MEDu for a subject has been determined, the three test sites will be demarcated. The test product and positive control (P3 reference sunscreen formulation) will be applied to two of the three test sites. The other test site will remain unprotected. All three test sites will be exposed to UV radiation at the expected MED and subsequently evaluated for erythema 16-24 hours after UV exposure.

Study Design

• Study Type: Interventional
• Actual Enrollment: 26 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Masking Description: The trained grader responsible for assessing Minimal Erythemal Dose of unprotected skin (MEDu) and Minimal Erythemal Dose of product treated (MEDp) at Visit 5 will be blinded to the product allocation of subjects. The trained grader responsible for assessing the provisional MEDu at Visit 3 will, necessarily, not be blinded since only one test site will be exposed to Ultraviolet (UV) radiation.
• Primary Purpose: Treatment
• Official Title: Determination of the Sun Protection Factor of a Cosmetic Daily Defence Skin Cream
• Actual Study Start Date: May 30, 2017
• Actual Primary Completion Date: Jun 30, 2017
• Actual Study Completion Date: Jun 30, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Test product This arm will include all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) will be applied.	Other: Physiogel Daily Defence Protective Day Cream Light; Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.
Active Comparator: Reference product This arm will include all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) will be applied.	Other: ISO 24444:2010 P3 Standard Sunscreen; Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.
No Intervention: Negative control This arm will include all the test sites on the participants back which will be left unprotected.

Outcome Measures

Primary Outcome Measures

1. Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value [Up to 24 hours post UV exposure]

   Arithmetical 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). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 70 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

• Subjects with a Fitzpatrick Skin Type of I, II or III

• Subjects with an Individual typological 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

• Subjects 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

• Subjects with a history of systemic therapy with anti-inflammatory agents or analgesics (e.g. diclofenac) up to 3 days prior to screening

• Subjects with dermatological conditions

• Subjects with a history of abnormal response to the sun

• Subjects who are tanned or have had sun exposure on the back area in the previous 4 weeks prior to screening

• Subjects having marks, blemishes or nevi or presenting existing sun damage in the test area

• Subjects having excessive hair, moles, tattoos, scars or other imperfections in the test area that could influence the investigation

• Subjects 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

• Subjects with a non-uniform skin colour or hyperpigmentation in the test area

• Subjects with a medical history of dysplastic nevi or melanoma

• Subjects with one of the following illnesses that might require regular systemic medication: Insulin-dependent diabetes, cancer

• Subjects with asthma, unless medicated

• Subjects with an electronic implant (e.g. pace maker, insulin pump, hearing aid) that cannot be removed during irradiation

• Acquired immune deficiency syndrome (AIDS) and infectious hepatitis, if known to the subjects

• 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

• Subjects who have used a tanning bed or other tanning treatment on the back area up to 1 month prior to screening

• Subjects accustomed to using tanning beds

• Subjects 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

• Subjects who will turn 71 years old before completing all assessment visits

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	GSK Investigational Site	Schenefeld	Schleswig-Holstein	Germany	22869

Sponsors and Collaborators

• GlaxoSmithKline

Investigators

• Study Director: GSK Clinical Trials, GlaxoSmithKline
• Study Director: GSK Clinical Trials, GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Study Documents (Full-Text)

• Study Protocol - May 11, 2017
• Statistical Analysis Plan - Jun 29, 2017

More Information

Publications

None provided.

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03136107
• Other Study ID Numbers: 207640
• First Posted: May 2, 2017
• Last Update Posted: Apr 19, 2019
• Last Verified: Jan 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Sunscreening Agents

Study Results

Participant Flow

Recruitment Details	All the participants were randomized at one center in Germany.

Arm/Group Title	All Participants
Arm/Group Description	There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule. All participants who were randomized to receive the study treatments were included.
Period Title: Overall Study
STARTED	26
Test Product	26
Reference Product	26
Negative Control	26
COMPLETED	25
NOT COMPLETED	1

Baseline Characteristics

Arm/Group Title	All Participants
Arm/Group Description	Baseline population included safety population (N=26), safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule.
Overall Participants	26
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	45.7 (14.27)
Sex: Female, Male (Count of Participants)
Female	23 88.5%
Male	3 11.5%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	0 0%
Asian	1 3.8%
Native Hawaiian or Other Pacific Islander	0 0%
Black or African American	0 0%
White	25 96.2%
More than one race	0 0%
Unknown or Not Reported	0 0%

Outcome Measures

1. Primary Outcome

Title	Arithmetic Mean of Individual Sun Protection Factor (SPFi) Value
Description	Arithmetical 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). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.
Time Frame	Up to 24 hours post UV exposure

Outcome Measure Data

Analysis Population Description

Intent to treat (ITT, N= 25) all valid participants data with no major protocol deviations were included in the SPF calculations. All participants exposed to Ultra Violet (UV) radiation were included the safety population, irrelevant of whether they successfully complete the study.

Arm/Group Title	Test Product	Reference Product
Arm/Group Description	This arm included all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) was applied.	This arm included all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) was applied.
Measure Participants	25	25
Mean (95% Confidence Interval) [Ratio (unit less)]	19.4	14.0

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Test Product, Reference Product
	Comments	CI % values (which is the percentage that half the 95 % CI represents of the mean values).
	Type of Statistical Test	Equivalence
	Comments	Statistical criterion defined in ISO 24444:2010 is that the 95 %CI is within ±17 % of the mean SPF
Statistical Test of Hypothesis	p-Value
	Comments
	Method
	Comments
Other Statistical Analysis		Test product CI of ±16.4% and reference product CI of ±16.6% of the mean SPF.

Adverse Events

Time Frame	Approximately 17 days
Arm/Group Title	Test Product		Reference Product		Negative Control		All Participants
Arm/Group Description	This arm included all the test sites on the participants back where test product (Physiogel Daily Defence Protective Day Cream Light) was applied.		This arm included all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) was applied.		This arm included all the test sites on the participants back which were left unprotected.		Safety population included all participants randomized and received any application of the study products.There were a total of 4 test sites assigned to each participant: 1) untreated skin for provisional MEDu assessment; 2) untreated skin for SPF assessment; 3) test product (Physiogel Daily Defence Protective Day Cream Light); and 4) reference product (ISO 24444:2010 P3 standard sunscreen). Test sites were delineated on the dorsum between the scapula and waist, either side of the spine. The test and reference products were applied topically to separate test sites by trained technician at a dose of 2 milligrams per square centimeter (mg/cm2) as per the randomization schedule.
All Cause Mortality
	Test Product		Reference Product		Negative Control		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)
Serious Adverse Events
	Test Product		Reference Product		Negative Control		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)
Other (Not Including Serious) Adverse Events
	Test Product		Reference Product		Negative Control		All Participants
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/26 (0%)		0/26 (0%)		0/26 (0%)		0/26 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

GSK agreements may vary with individual investigators, but will not prohibit any investigator from publishing. GSK supports the publication of results from all centers of a multi-center trial but requests that reports based on single-site data not precede the primary publication of the entire clinical trial.