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

NCT ID: NCT03136107

Last Updated: 2019-04-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 26 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2017-05-30
• Study Completion Date: 2017-06-30

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).

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.

Conditions

Sunscreening Agents

Study Design

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

Study Groups

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.

Group Type: EXPERIMENTAL

Physiogel Daily Defence Protective Day Cream Light

Intervention Type: OTHER

Investigator controlled, topical application to the epidermis at a dose of 2 milligrams per square centimeter (mg/cm2). Single application.

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.

Group Type: ACTIVE_COMPARATOR

ISO 24444:2010 P3 Standard Sunscreen

Intervention Type: OTHER

Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.

Negative control

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

Interventions

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.

Intervention Type: OTHER

ISO 24444:2010 P3 Standard Sunscreen

Investigator controlled, topical application to the epidermis at a dose of 2 mg/cm2. Single application.

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
• 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

• 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

207640

Identifier Type: -

Identifier Source: org_study_id