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

GlaxoSmithKline (GSK)

Status: Completed

Conditions: Sunscreening Agents

Treatments: Other: NGBUV000B, (Expected SPF 30); Other: Sunscreen formulation S2; Other: NGBUV000C, (Expected SPF 30); Other: NGBUV000A, (Expected SPF 30); Other: Glycerin; Other: P3 Standard, (Expected SPF 16); Other: NGBUV000D, (Expected SPF 30)

Study type: Interventional

Funder types: Industry

Identifiers

NCT03157583

207583

Details and patient eligibility

About

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.

Full 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).

Enrollment: 8 patients

Sex: All

Ages: 18 to 70 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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8 participants in 8 patient groups

Reference product (for SPFi calculation)

Active Comparator group

Description:

This arm will include all the test sites on the participants back where reference product (P3 standard sunscreen) will be applied.

Treatment:

Other: P3 Standard, (Expected SPF 16)

Test product 1

Experimental group

Description:

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.

Treatment:

Other: NGBUV000A, (Expected SPF 30)

Test product 2

Experimental group

Description:

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.

Treatment:

Other: NGBUV000B, (Expected SPF 30)

Test product 3

Experimental group

Description:

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.

Treatment:

Other: NGBUV000C, (Expected SPF 30)

Test product 4

Experimental group

Description:

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.

Treatment:

Other: NGBUV000D, (Expected SPF 30)

Negative control (for SPFi calculation)

No Intervention group

Description:

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

Reference (for UVAPFi calculation)

Active Comparator group

Description:

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

Treatment:

Other: Sunscreen formulation S2

Blank control (for UVAPFi calculation)

Other group

Description:

This arm will include blank test plates treated with glycerin.

Treatment:

Other: Glycerin