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N/A N=8 Randomized Single-blind Treatment

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

Sunscreening Agents

Enrolled (actual)
8
Serious AEs
0.0%
Results posted
Jul 2019
Primary outcome: Primary: Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values — 33.1; 35.2; 35.2; 45.2 Ratio

Study Design & Population

Study type
Interventional
Phase
N/A
Interventions
NGBUV000A, (Expected SPF 30) (Other); NGBUV000B, (Expected SPF 30) (Other); NGBUV000C, (Expected SPF 30) (Other); NGBUV000D, (Expected SPF 30) (Other); P3 Standard, (Expected SPF 16) (Other); Sunscreen formulation S2 (Other); Glycerin (Other)
Age
Adult, Older Adult · 18+ yrs
Sex
All
Sponsor
GlaxoSmithKline
Primary completion
Jul 2017

Outcome Measures

OutcomeResultp-value
PRIMARY
Arithmetic Mean of Individual Sun Protection Factor (SPFi) Values
33.1; 35.2; 35.2; 45.2; 15.6
SECONDARY
Spectrum of Sun Protection
3.11; 2.98; 2.88; 2.95; 1.13

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.

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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT03157583). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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