In Vivo Sun Protection Factor Determination | NCT02792595

NCT02792595

Protocol Section

Identification Module

Results Section

No data available

No data is available for this block.

Annotation Section

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No data is available for this block.

Document Section

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No data is available for this block.

Derived Section

Miscellaneous Info Module

Status Module

Oversight Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Negative Control	Sham Comparator	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
Positive Control	Active Comparator	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
Test Product A	Experimental	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.

Name	Type	Description	Arm Group Labels	Other Names
Negative Control	Other	Untreated area	Negative Control
Positive Control

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Eligibility Module

Eligibility Criteria

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