Cetaphil
DrugSubjects 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.
NCT Number: NCT07398989
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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Notify Me40 year–60 year
All sexes
Interventional
Phase 4
Ablon Skin Institute & Research Center, Manhattan Beach, California, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
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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.
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Time frame: Baseline, Week 4, Week 8, Week 12
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.
Time frame: Baseline, Week 12
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.
Time frame: Baseline, Week 12
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.
Galderma R&D
Industry
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View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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