In Vivo Sun Protection Factor Determination

Not Applicable

Completed

• Conditions: Skin Care

• Registration Number: NCT02792595
• Lead Sponsor: GlaxoSmithKline

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-06
• Study First Submitted: 2015-06-25
• Primary Completion: 2015-07
• Study Completion: 2015-07
• Status Verified: 2016-06
• Study First Submitted QC: 2016-06-02
• Study First Posted: 2016-06-07
• Last Update Submitted: 2016-06-16
• Last Update Posted: 2016-06-20

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 28

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Visual evaluation of irradiated skin	Upto 2 weeks	Visual evaluation of irradiated test area will be carried out to determine Minimal Erthemal Dose (MED). The lowest irradiation dose producing perceptible erythema will be chosen as MED. The individual SPF (SPFi) for each test product will be determined by calculating the ratio of the MED on test product protected skin (MEDp) to the MED on unprotected skin (MEDu).

Trial Locations

Locations (1)

GSK Investigational Site; 🇩🇪 Schenefeld, Schleswig-Holstein, Germany