In Vivo Sun Protection Factor Determination

Skin Care Clinical Trial

Official title:

Sun Protection Factor Determination (In Vivo Determination of the Sun Protection Factor ISO 24444) (61-SPF-iM)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02792595
• Other study ID #: 204736
• Status: Completed
• Phase: N/A
• First received: June 25, 2015
• Last updated: June 16, 2016
• Start date: June 2015
• Est. completion date: July 2015

Study information

• Verified date: June 2016
• Source: GlaxoSmithKline
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Independent Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 28
• Est. completion date: July 2015
• Est. primary completion date: July 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Double Blind (Subject, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Skin Care

Intervention

Other:
• Negative Control
Untreated area
• Positive Control
High SPF Standard P3/SPF 15
• Test Product A
Yosemite Falls (Forte Day SPF upgrade) Variant A
• Test Product B
Yosemite Falls (Forte Day SPF upgrade) Variant B
• Test Product C
Yosemite Falls (Forte Day SPF upgrade) Variant C
• Test Product D
Yosemite Falls (Forte Day SPF upgrade) Variant D
• Test Product E
Yosemite Falls (Forte Day SPF upgrade) Variant E
• Test Product F
Yosemite Falls (Forte Day SPF upgrade) Variant F
• Test Product G
Yosemite Falls (Forte Day SPF upgrade) Variant G
• Test Product H
Yosemite Falls (Forte Day SPF upgrade) Variant H

Locations

Country	Name	City	State
Germany	GSK Investigational Site	Schenefeld	Schleswig-Holstein

Sponsors (1)

Lead Sponsor	Collaborator
GlaxoSmithKline

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual evaluation of irradiated skin	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).	Upto 2 weeks	No