A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations

• ClinicalTrials.gov Identifier: NCT03157583
• Recruitment Status: Completed
• First Posted: May 17, 2017
• Results First Posted: July 22, 2019
• Last Update Posted: July 22, 2019
• Sponsor: GlaxoSmithKline
• Information provided by (Responsible Party): GlaxoSmithKline

Study Description

Brief Summary:

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.

Condition or disease	Intervention/treatment	Phase
Sunscreening Agents	Other: NGBUV000A, (Expected SPF 30); Other: NGBUV000B, (Expected SPF 30); Other: NGBUV000C, (Expected SPF 30); Other: NGBUV000D, (Expected SPF 30); Other: P3 Standard, (Expected SPF 16); Other: Sunscreen formulation S2; Other: Glycerin	Not Applicable

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 Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 8 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
• Actual Study Start Date: June 21, 2017
• Actual Primary Completion Date: July 7, 2017
• Actual Study Completion Date: July 7, 2017

Arms and Interventions

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.	Other: P3 Standard, (Expected SPF 16); 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.
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.	Other: NGBUV000A, (Expected SPF 30); 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.	Other: NGBUV000B, (Expected SPF 30); 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.	Other: NGBUV000C, (Expected SPF 30); 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.
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.	Other: NGBUV000D, (Expected SPF 30); 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.
No Intervention: Negative control (for SPFi calculation); This arm will include all the test sites on the participants back which will be left unprotected.
Active Comparator: Reference (for UVAPFi calculation); This arm will include test plates treated with reference sunscreen formulation S2.	Other: Sunscreen formulation S2; A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.
Blank control (for UVAPFi calculation); This arm will include blank test plates treated with glycerin.	Other: Glycerin; A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.

Outcome Measures

Primary Outcome Measures :

1. 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.

Secondary Outcome Measures :

1. Spectrum of Sun Protection [ Time Frame: Up to 30 minutes post UV exposure ]
   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.

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 70 Years (Adult, Older Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

Criteria

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

Contacts and Locations

Locations

Germany

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)

Documents provided by GlaxoSmithKline:

Study Protocol  [PDF] May 18, 2017

Statistical Analysis Plan  [PDF] July 3, 2017

More Information

• Responsible Party: GlaxoSmithKline
• ClinicalTrials.gov Identifier: NCT03157583
• Other Study ID Numbers: 207583
• First Posted: May 17, 2017
• Results First Posted: July 22, 2019
• Last Update Posted: July 22, 2019
• Last Verified: May 2019

Individual Participant Data (IPD) Sharing Statement:

• 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; Glycerol; Radiation-Protective Agents; Protective Agents; Physiological Effects of Drugs; Dermatologic Agents; Cryoprotective Agents