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

NCT03136107 | Completed Results

• 1 other identifier: 207640
• Study Type: interventional
• Target: 26
• Locations: 1 country
• Sites: 1

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).

Conditions

Sunscreening Agents

Outcome Measures

Primary Outcomes (1)

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

  Arithmetical 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). The Minimal Erythemal Dose (MED) was defined as the lowest dose of UV radiation that produced the first perceptible unambiguous erythema with defined borders appearing over most of the field of UV exposure, 16 to 24 hours after UV exposure. No inferential statistical analysis has been performed for this outcome. Test and reference products achieved a 95% CI of ±16.4% and ±16.6% of the mean SPF. These data meet the statistical criterion defined in ISO 24444:2010 as the 95% CI is within ±17% of the mean SPF.

  Up to 24 hours post UV exposure

Study Arms (3)

Test product

EXPERIMENTAL

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.

Other: Physiogel Daily Defence Protective Day Cream Light

Reference product

ACTIVE COMPARATOR

This arm will include all the test sites on the participants back where reference product (ISO 24444:2010 P3 standard sunscreen) will be applied.

Other: ISO 24444:2010 P3 Standard Sunscreen

Negative control

NO INTERVENTION

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

Interventions

Physiogel Daily Defence Protective Day Cream Light OTHER

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

Test product

ISO 24444:2010 P3 Standard Sunscreen OTHER

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

Reference product

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
• Subjects with a Fitzpatrick Skin Type of I, II or III
• Subjects with an Individual typological 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
• 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

Sponsors & Collaborators

• GlaxoSmithKline: lead

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

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
• Masking Details: The trained grader responsible for assessing Minimal Erythemal Dose of unprotected skin (MEDu) and Minimal Erythemal Dose of product treated (MEDp) at Visit 5 will be blinded to the product allocation of subjects. The trained grader responsible for assessing the provisional MEDu at Visit 3 will, necessarily, not be blinded since only one test site will be exposed to Ultraviolet (UV) radiation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 27, 2017
• First Posted: May 2, 2017
• Study Start: May 30, 2017
• Primary Completion: June 30, 2017
• Study Completion: June 30, 2017
• Last Updated: April 19, 2019
• Results First Posted: April 19, 2019

Record last verified: 2019-01

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)