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Subjects having mild-to-moderate crepiness, photodamage, and loss of firmness will apply a topical skincare regimen to the knees, thighs, hands, and all over the body. Evaluations of the regimen's efficacy will be conducted at 4 weeks, 8 weeks, and 12 weeks post-baseline.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Skincare Product Treatment | Experimental | Subjects will apply topical skincare products to the body. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cetaphil | Drug | Subjects will apply Cetaphil Hydrating and Firming Cream Skin Activator to the knees, thighs, hands, and all of the body at least twice daily. Subjects will use Cetaphil Daily Facial Moisturizer SPF 35 as needed. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of clinical grading compared to baseline | Clinical grading of efficacy parameters will be performed at both study sites. The efficacy parameters will be assessed by the Investigators at the knees and lower thighs using a modified Griffiths' 10-point scale , with 0 indicating best possible condition and 9 indicating worst possible condition. Half-point scores may be used as necessary to more accurately describe the skin condition. A decrease in scores indicates an improvement. | Baseline, Week 4, Week 8, Week 12 |
| Change in skin hydration as measured by Corneometer | Corneometer (Courage + Khazaka, Germany) measurements will be taken in triplicate to assess skin hydration. The Corneometer measures in Corneometer units from 0 (no water at all) - 120 (on water). Measurements will be taken on the lower thigh/upper knee at 9 locations. An increase in scores indicates an improvement. | Baseline, Week 4, Week 8, Week 12 |
| Change in tolerability grading compared to baseline | Tolerability assessment will be evaluated at both study sites. The areas for evaluation on the body are knees and lower thighs. Investigator will assess erythema, edema, and dryness using a 4-point analog scale (with half-point scores used as necessary to better describe the clinical condition). A score of 0 indicates best possible condition, and a score of 3 indicates worst possible condition. | Baseline, Week 4, Week 8, Week 12 |
| Change in skin quality measured by macroscopic imaging (Visioscan) | Macroscopic imaging procedure of skin texture will be performed using Visioscan® VC 20plus on all subjects, at Site 1 only. Images will be taken of each subject's upper knee (left or right). Imaging location will be the same at each timepoint. | Baseline, Week 4, Week 8, Week 12 |
| Measured pH values consistent with baseline |
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| Measure | Description | Time Frame |
|---|---|---|
| Visual change in bruising intensity compared to baseline | Bruise induction procedure will be performed on all subjects at Site 2 only. At Baseline and D84/W12, subjects will participate in a cupping procedure after all assessments are completed to induce bruising. Bruising intensity will be visually assessed on the Bruise Visibility Scale, which is a 1-5 scale, with 1 indicating the bruise is barely visible, and 5 indicating the bruise is prominently or unmistakably visible. A decrease in scores indicates an improvement. |
Inclusion Criteria:
Exclusion Criteria:
Pregnant, breastfeeding, or planning pregnancy during the course of the study. 2. Subject with any known allergies or hypersensitivity to any cosmetics, personal care products, and/or fragrances. 3. History of cancer within the past 5 years 4. History or presence of any skin condition/dermatologic disease on the test areas (knees, lower thighs, hands) that might interfere with the evaluation of study parameters and/or put the subject at significant risk (according to the Investigator's judgment) if the subject takes part to the trial. 5. Planning on having surgeries and/or invasive medical procedures during the course of the study. 6. For biopsy subgroup at Site 1 and all subjects at Site 2:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Ablon Skin Institute & Research Center | Manhattan Beach | California | 90266 | United States | ||
| Clinical Research Center of the Carolinas |
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| ID | Term |
|---|---|
| C011189 | cetyl alcohol, propylene glycol, sodium lauryl sulfate non-lipid cleansing lotion |
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Skin pH measurements will be performed using pH Meter on all subjects, at Site 1 only. Triplicate measurements will be taken on the upper knee (left or right). pH value will be expressed in two decimals. A lack of significant change in values indicates maintenance of skin pH. |
| Baseline, Week 4, Week 8, Week 12 |
| Baseline, Week 12 |
| Change in bruising duration compared to baseline bruise induction | Bruise induction procedure will be performed on all subjects at Site 2 only. At Baseline and D84/W12, subjects will participate in a cupping procedure after all assessments are completed to induce bruising. Subjects will capture photos of the bruises daily until bruise resolution. A decrease in bruise duration indicates an improvement in bruise resolution. | Baseline, Week 12 |
| Charleston |
| South Carolina |
| 29407 |
| United States |