Clinical trial NCT03157583: A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
Official title: Determination of the Sun Protection Factor (SPF) and in Vitro UVA Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Sunscreening Agents
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2017-05-17
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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).

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

Primary outcomes:
measure: Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
timeFrame: Up to 24 hours post UV exposure
Secondary outcomes:
measure: Spectrum of Sun Protection
timeFrame: Up to 30 minutes post UV exposure
Other outcomes:
Locations:
city: Schenefeld
country: Germany
facility: GSK Investigational Site
state: Schleswig-Holstein
Study officials:
affiliation: GlaxoSmithKline
name: GSK Clinical Trials
role: STUDY_DIRECTOR
affiliation: GlaxoSmithKline (for GlaxoSmithKline; Human Genome Sciences Inc., a GSK Company; Sirtris, a GSK Company; Stiefel, a GSK Company; ViiV Healthcare)
name: GSK Clinical Trials
role: STUDY_DIRECTOR
References: