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

NCT03157583 | Completed Results

• 1 other identifier: 207583
• Study Type: interventional
• Target: 8
• Locations: 1 country
• Sites: 1

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.

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

• Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values

  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.

  Up to 24 hours post UV exposure

Secondary Outcomes (1)

• Spectrum of Sun Protection

  Up to 30 minutes post UV exposure

Study Arms (8)

Reference product (for SPFi calculation)

ACTIVE COMPARATOR

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)

Test product 1

EXPERIMENTAL

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)

Test product 2

EXPERIMENTAL

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)

Test product 3

EXPERIMENTAL

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)

Test product 4

EXPERIMENTAL

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)

Negative control (for SPFi calculation)

NO INTERVENTION

This arm will include all the test sites on the participants back which will be left unprotected.

Reference (for UVAPFi calculation)

ACTIVE COMPARATOR

This arm will include test plates treated with reference sunscreen formulation S2.

Other: Sunscreen formulation S2

Blank control (for UVAPFi calculation)

OTHER

This arm will include blank test plates treated with glycerin.

Other: Glycerin

Interventions

NGBUV000A, (Expected SPF 30) OTHER

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.

Test product 1

NGBUV000B, (Expected SPF 30) OTHER

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.

Test product 2

NGBUV000C, (Expected SPF 30) OTHER

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.

Test product 3

NGBUV000D, (Expected SPF 30) OTHER

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.

Test product 4

P3 Standard, (Expected SPF 16) OTHER

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.

Reference product (for SPFi calculation)

Sunscreen formulation S2 OTHER

A total of 1.3 mg/cm2 of sunscreen formulation S2 will be applied to the test plates.

Reference (for UVAPFi calculation)

Glycerin OTHER

A total of 1.3 mg/cm2 of glycerin will be applied to the test plates.

Blank control (for UVAPFi calculation)

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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°

You may not qualify if:

• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

MeSH Terms

Interventions

Glycerol

Intervention Hierarchy (Ancestors)

Triose Sugar Alcohols; Sugar Alcohols; Alcohols; Organic Chemicals; Carbohydrates

Results Point of Contact

• Title: GSK Response Center
• Organization: GlaxoSmithKline

GSKClinicalSupportHD@gsk.com

866-435-7343

Study Officials

• 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 DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 16, 2017
• First Posted: May 17, 2017
• Study Start: June 21, 2017
• Primary Completion: July 7, 2017
• Study Completion: July 7, 2017
• Last Updated: July 22, 2019
• Results First Posted: July 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)