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Completed

NCT Number: NCT02792595

In Vivo Sun Protection Factor Determination

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.

Completed

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Key information

Conditions

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Negative Control

Other

Untreated area

Positive Control

Other

High SPF Standard P3/SPF 15

Test Product A

Other

Yosemite Falls (Forte Day SPF upgrade) Variant A

Test Product B

Other

Yosemite Falls (Forte Day SPF upgrade) Variant B

Test Product C

Other

Yosemite Falls (Forte Day SPF upgrade) Variant C

Test Product D

Other

Yosemite Falls (Forte Day SPF upgrade) Variant D

Test Product E

Other

Yosemite Falls (Forte Day SPF upgrade) Variant E

Test Product F

Other

Yosemite Falls (Forte Day SPF upgrade) Variant F

Test Product G

Other

Yosemite Falls (Forte Day SPF upgrade) Variant G

Test Product H

Other

Yosemite Falls (Forte Day SPF upgrade) Variant H

Primary outcomes

  1. Visual evaluation of irradiated skin

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

GlaxoSmithKline

Industry

Registry information

Official study title

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

Important dates

Study start
2015
Primary completion
2015
Study completion
2015
First posted
Jun 7, 2016
Registry last updated
Jun 20, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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