In Vivo Sun Protection Factor Determination

June 16, 2016 updated by: GlaxoSmithKline

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
28

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Schleswig-Holstein
      • Schenefeld, Schleswig-Holstein, Germany, 22869
        • GSK Investigational Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Single Group Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Sham Comparator: Negative Control
Untreated area will be irradiated using a sun simulator with UV irradiation increment of 1.25 to detect MED of the unprotected skin.
Other: Negative Control
Untreated area
Active Comparator: Positive Control
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, positive control will be applied. The dose of positive control will be measured in accordance to the application volume (2 milligram (mg)/centimeter (cm)^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Positive control will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 seconds (s). After waiting for 15 to 30 minutes (min), the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the SPF of positive control, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Positive Control
High SPF Standard P3/SPF 15
Experimental: Test Product A
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product A
Yosemite Falls (Forte Day SPF upgrade) Variant A
Experimental: Test Product B
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product B
Yosemite Falls (Forte Day SPF upgrade) Variant B
Experimental: Test Product C
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product C
Yosemite Falls (Forte Day SPF upgrade) Variant C
Experimental: Test Product D
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product D
Yosemite Falls (Forte Day SPF upgrade) Variant D
Experimental: Test Product E
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product E
Yosemite Falls (Forte Day SPF upgrade) Variant E
Experimental: Test Product F
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product F
Yosemite Falls (Forte Day SPF upgrade) Variant F
Experimental: Test Product G
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product G
Yosemite Falls (Forte Day SPF upgrade) Variant G
Experimental: Test Product H
After irradiation of the test area with a sun simulator with an increment of UV radiation of 1.25, test product will be applied. The dose of test product will be measured in accordance to the application volume (2 mg/cm^2 (± 0.05 mg/cm^2) and it will be applied using a micro litre syringe in approximately 15-30 small droplets all over the test area. Test product will be then quickly spread by gently rubbing with a non-saturated finger cot, first with rotating followed by crosswise movements for a final uniform coating on the skin. Spreading time will be between 20 and 50 s. After waiting for 15 to 30 min, the test area will be again irradiated (increment of 1.12 or 1.25) with the sun simulator. The irradiation time will depend on the expected SPF of the test product, participants' skin prototype, determined MED after irradiation and actual power of sun simulator.
Other: Test Product H
Yosemite Falls (Forte Day SPF upgrade) Variant H

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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).
Upto 2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
GlaxoSmithKline

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 1, 2015

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2015

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
June 25, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 2, 2016

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 7, 2016

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 20, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 16, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
June 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 204736

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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