- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02792595
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
Completed
Conditions
Study Type
Interventional
Enrollment (Actual)
28
Phase
- 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
-
-
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
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 |
Intervention / Treatment |
---|---|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
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.
|
Yosemite Falls (Forte Day SPF upgrade) Variant H
|
What is the study measuring?
Primary Outcome Measures
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
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
June 1, 2015
Primary Completion (Actual)
July 1, 2015
Study Completion (Actual)
July 1, 2015
Study Registration Dates
First Submitted
June 25, 2015
First Submitted That Met QC Criteria
June 2, 2016
First Posted (Estimate)
June 7, 2016
Study Record Updates
Last Update Posted (Estimate)
June 20, 2016
Last Update Submitted That Met QC Criteria
June 16, 2016
Last Verified
June 1, 2016
More Information
Terms related to this study
Other Study ID 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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