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

NCT ID: NCT03157583

Last Updated: 2019-07-22

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 8 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-06-21
• Study Completion Date: 2017-07-07

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.

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).

Conditions

Sunscreening Agents

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: SINGLE

Study Groups

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.

Group Type: ACTIVE_COMPARATOR

P3 Standard, (Expected SPF 16)

Intervention Type: 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.

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.

Group Type: EXPERIMENTAL

NGBUV000A, (Expected SPF 30)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

NGBUV000B, (Expected SPF 30)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

NGBUV000C, (Expected SPF 30)

Intervention Type: 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 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.

Group Type: EXPERIMENTAL

NGBUV000D, (Expected SPF 30)

Intervention Type: 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.

Negative control (for SPFi calculation)

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Reference (for UVAPFi calculation)

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

Group Type: ACTIVE_COMPARATOR

Sunscreen formulation S2

Intervention Type: OTHER

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.

Group Type: OTHER

Glycerin

Intervention Type: OTHER

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

Interventions

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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: 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.

Intervention Type: OTHER

Sunscreen formulation S2

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

Intervention Type: OTHER

Glycerin

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

Intervention Type: OTHER

Eligibility 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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

GlaxoSmithKline

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)

Locations

GSK Investigational Site

Schenefeld, Schleswig-Holstein, Germany

Countries

Germany

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

207583

Identifier Type: -

Identifier Source: org_study_id