N/A
N=8
A Study to Measure the Sun Protection Factor (SPF) and Ultraviolet-A Protection Factor (UVAPF) of Four Developmental Sunscreen Formulations
Sunscreening Agents
Bottom Line
View on ClinicalTrials.gov: NCT03157583 ↗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
| Outcome | Result | p-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
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.