Clinical trial NCT02792595: In Vivo Sun Protection Factor Determination
Official title: Sun Protection Factor Determination (In Vivo Determination of the Sun Protection Factor ISO 24444) (61-SPF-iM)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Skin Care
Lead sponsor: GlaxoSmithKline
Sponsor class: INDUSTRY
First posted: 2016-06-07
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: BASIC_SCIENCE

Brief summary: The study aims to determine the Sun Protection Factor (SPF) of 8 cosmetic products in vivo on the back of human participants, according to the International Standard Sun Protection Test method by using a sun simulator.


Eligibility criteria: Inclusion Criteria:

* Understanding of the study and willingness to participate as demonstrated by voluntary written informed consent
* Age between 18 to 70 years (inclusive)
* Uniform skin and no erythema or dark pigmentation in the test area
* Skin type I, II or III according to Fitzpatrick scale
* Individual typological angle (ITA°) \> 28 in the test area
* Willingness to discontinue the use of detergents, cosmetic products in the treatment areas and to avoid any exposure of the test area to artificial or natural ultraviolet (UV) light throughout the study

Exclusion Criteria:

* Breast feeding, pregnant women or who are intending to become pregnant over study duration
* Acquired immunodeficiency syndrome (AIDS) or infectious hepatitis, insulin dependent diabetes, cancer, active skin disease at the test area, asthma or hypertension if not medicated, medical history of dysplastic nevi or melanoma, allergies to cosmetic products
* Electronic implant that cannot be removed during irradiation
* Sun exposition, UV therapy, artificial tanning within the last 4 weeks, or irregularly tanned skin in the test area
* Application of leave-on cosmetics at the test area within the last 24 h prior to the study start
* Moles, tattoos, scars, irritated skin, hair, etc. at the test area that could influence the investigation
* Usage of medications with known photo-toxic and/or photo-sensitizing potential within the last 14 days prior to study start and/or throughout the entire study course
* Systemic therapy with immuno-suppresive drugs and/or antihistamines within last 7 days prior to study start and/or throughout the entire study course
* Systemic therapy with anti-phlogistic agents or analgetics within last 3 days prior to study start and/or throughout the entire study course
* Participation or in waiting period of 2 months after participation in similar cosmetic and/or pharmaceutical UV studies
* Known or suspected intolerance or hypersensitivity to cosmetic products
* Alcohol or other substance of abuse within the last 5 years
* Employee of the sponsor or the study site or members of their immediate family

Primary outcomes:
measure: Visual evaluation of irradiated skin
timeFrame: Upto 2 weeks
Secondary outcomes:
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
References: