NCT02792595

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2015

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2015

Completed
24 days until next milestone

First Submitted

Initial submission to the registry

June 25, 2015

Completed
6 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
11 months until next milestone

First Posted

Study publicly available on registry

June 7, 2016

Completed
Last Updated

June 20, 2016

Status Verified

June 1, 2016

Enrollment Period

1 month

First QC Date

June 25, 2015

Last Update Submit

June 16, 2016

Conditions

Skin Care

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (10)

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.

Other: Test Product A

Test Product B

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.

Other: Test Product B

Test Product C

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.

Other: Test Product C

Test Product D

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.

Other: Test Product D

Test Product E

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.

Other: Test Product E

Test Product F

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.

Other: Test Product F

Test Product G

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.

Other: Test Product G

Test Product H

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.

Other: Test Product H

Interventions

Negative ControlOTHER

Untreated area

Negative Control
Positive ControlOTHER

High SPF Standard P3/SPF 15

Positive Control
Test Product AOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant A

Test Product A
Test Product BOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant B

Test Product B
Test Product COTHER

Yosemite Falls (Forte Day SPF upgrade) Variant C

Test Product C
Test Product DOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant D

Test Product D
Test Product EOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant E

Test Product E
Test Product FOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant F

Test Product F
Test Product GOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant G

Test Product G
Test Product HOTHER

Yosemite Falls (Forte Day SPF upgrade) Variant H

Test Product H

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

GSK Investigational Site

Schenefeld, Schleswig-Holstein, 22869, Germany

Location

Study Officials

  • GSK Clinical Trials

    GlaxoSmithKline

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 25, 2015

First Posted

June 7, 2016

Study Start

June 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

June 20, 2016

Record last verified: 2016-06

Locations

DE(1)