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Evaluation of age-related skin changes using clinical probe measurements and imaging modalities in Chinese subjects.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group 1 | |||
| Group 2 | |||
| Group 3 | |||
| Group 4 | |||
| Group 5 | |||
| Group 6 |
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| Measure | Description | Time Frame |
|---|---|---|
| Age-related changes in skin hydration on the cheeks, forehead, neck and around the mouth | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. | 2 Months |
| Age-related changes in skin elasticity on the cheeks, forehead and neck | Skin elasticity measurement using suction based device | 2 Months |
| Age-related changes in skin color on the cheeks and forehead | Skin colorimetric measurement will be done with a Spectrophotometer | 2 Months |
| Age-related changes in skin thickness on the cheek | Epidermal thickness will be measured with an optical coherence tomography instrument | 2 Months |
| Age-related changes in skin blood flow on the cheek | Blood Flow (redness) will be measured with an optical coherence tomography instrument | 2 Months |
| Age-related changes in skin roughness on the cheek | Skin surface roughness will be measured with an optical coherence tomography instrument | 2 Months |
| Age-related changes in skin OAC on the cheek | Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument |
| Measure | Description | Time Frame |
|---|---|---|
| To correlate the age-related skin hydration measurements on the cheeks, forehead, neck and around the mouth to clinical scoring of fine lines and skin smoothness. | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. | 2 Months |
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Inclusion Criteria:
Exclusion Criteria:
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Female and male Chinese subjects, between 20 and 79 years old, will be included in the study. Subjects will be divided in 6 age-categories: 20-29, 30-39, 40-49, 50-59, 60-69, 70-79 years (at least 10 subjects per decade and remainder of subjects distributed among the groups) in order to evaluate age-related skin changes.
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| Name | Affiliation | Role |
|---|---|---|
| Min Liu, MD | Eurofins China | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Eurofins China | Haizhu | Guangzhou | 510032 | China |
Allergan will share de-identified patient-level data and study-level data including protocols and clinical study reports for phase 2 - 4 trials completed after 2008 that are registered to ClinicalTrials.gov or EudraCT, have received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published. To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes. More information can be found on http://www.allerganclinicaltrials.com/.
After having received regulatory approval in the United States and/or the European Union in a given indication and the primary manuscript from the trial has been published.
To request access to the data, the researcher must sign a data use agreement and any shared data is to be used for non-commercial purposes.
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| 2 Months |
| Age-related changes in skin topography on the cheeks, forehead and around the mouth | Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of the roughness profile) | 2 Months |
| Age-related changes in gloss/shine, pores, skin color and texture on the cheek, forehead and around the mouth | Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features | 2 Months |
| Clinical scoring of age-related changes in fine lines on the cheek | The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse) | 2 Months |
| Clinical scoring of age-related changes in skin roughness on the cheek | The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse) | 2 Months |
| To correlate the age-related skin elasticity measurements on the cheeks, forehead and neck to clinical scoring of fine lines and skin smoothness. | Skin elasticity measurement using suction based device | 2 Months |
| To correlate the age-related skin color measurements on the cheeks and forehead to clinical scoring of fine lines and skin smoothness. | Skin colorimetric measurement will be done with a Spectrophotometer | 2 Months |
| To correlate the age-related skin thickness measurements on the cheek to clinical scoring of fine lines and skin smoothness. | Epidermal thickness will be measured with an optical coherence tomography instrument | 2 Months |
| To correlate the age-related skin blood flow measurements on the cheek to clinical scoring of fine lines and skin smoothness. | Blood Flow (redness) will be measured with an optical coherence tomography instrument | 2 Months |
| To correlate the age-related skin roughness measurements on the cheek to clinical scoring of fine lines and skin smoothness. | Skin surface roughness will be measured with an optical coherence tomography instrument | 2 Months |
| To correlate the age-related skin OAC measurements on the cheek to clinical scoring of fine lines and skin smoothness. | Optical Attenuation Coefficient (OAC) will be measured with an optical coherence tomography instrument | 2 Months |
| To correlate the age-related skin topography measurements on the cheeks, forehead and around the mouth to clinical scoring of fine lines and skin smoothness. | Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of the roughness profile) | 2 Months |
| To correlate the age-related gloss/shine, pores, skin color and texture on the cheek, forehead and around the mouth to clinical scoring of fine lines and skin smoothness. | Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features | 2 Months |
| To correlate the age-related fine lines on the cheek to clinical scoring of fine lines and skin smoothness. | The investigator will assess the participant's appearance of fine lines/wrinkles using a 5-point scale from (0=None to 4=Diffuse) | 2 Months |
| To correlate the age-related skin roughness on the cheek to clinical scoring of fine lines and skin smoothness. | The investigator will assess the participant's appearance of skin roughness using a 5-point scale from (0=None to 4=Diffuse) | 2 Months |
| Age-related changes and repeatability in the perioral area for hydration and topography. | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of theroughness profile) | 2 Months |
| Age-related changes and repeatability in the neck for hydration and elasticity. | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. Skin elasticity measurement using suction based device | 2 Months |
| Age related changes and repeatability in the forehead for hydration, color, elasticity, topography, skin gloss, color, texture, pores. | Skin hydration will be measured using tissue dielectric constant measurement. Tissue dielectric constant is expressed as a unitless value that is directly proportional to the amount of water in the tissue. Skin colorimetric measurement will be done with a Spectrophotometer. Skin elasticity measurement using suction based device. Skin topography imaged using a using a fringe projection imaging system. Output measurements from the images will include Ra (average roughness), Rq (Root Mean Square of the profile heights), RMax (Maximum Roughness Depth), Rv (Depth of the Largest Profile Valley), Rvm (Average depth of the Profile Valleys), Rz (average height of roughness) and Rt (maximum height of the roughness profile). Skin gloss (Shine, pores, skin color and texture ) imaged using a camera-based system which uses various lighting/capture modalities to enhance the visualization of skin features. | 2 Months |