A Phase IV Open-label Trial Assessing the Impact on Skin Quality, Hydration, and Barrier of Three (3) Hydrafacial Treatments in Adults of Fitzpatrick Skin Types I-VI
Sponsor study identifier
interventional
27
1 country
2
Study Start
November 20, 2023
Actual (reported)Primary Completion
October 9, 2024
Actual (reported)Study Completion
October 9, 2024
Actual (reported)This is a phase IV, unblinded, open-label study assessing the impact on skin quality, hydration, and barrier of three (3) Hydrafacial treatments in healthy adults of Fitzpatrick Skin Types I \& II, III, IV, V \& VI, 30 to 55 years of age. Efficacy and subject satisfaction will be assessed, before and after three (3) HF treatments, in 6 patient cohorts, each cohort defined by FST I-VI.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
October 9, 2024
Actual (reported)Click on a node to explore related trials.
Some registry-reported names shown below are not yet linked in this graph.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
June 15, 2023
Actual (reported)July 6, 2023
Actual (reported)November 20, 2023
Actual (reported)October 9, 2024
Actual (reported)October 9, 2024
Actual (reported)Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size
Measured by Investigator assessment using the validated Scientific Assessment Scale of Skin Quality. the scale assesses the facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, and erythema. The parameters include 0 = none (best possible outcome), 1 = mild, 2 = moderate, 3 = severe, and 4 = very severe (worst possible outcome). Pore size will be measured using parameters of 0 = fine (best possible outcome), 1 = small, 2 = moderate, 3 = large, and 4 = very large (worst possible outcome).
Change from Baseline to Day 85
Change in facial aesthetic appearance
Measured by the Investigator Global Aesthetic Improvement Scale. Scale and parameters include 1 = worst (worst possible outcome), 2 = mildly improved, 3 = improved, 4 = much improved, and 5 = very much improved (best possible outcome).
Change from Baseline to Day 85
Change in subjective irritation parameters
Measured by the Investigator Tolerability Assessment. Scale includes burning, stinging, and itching. Each will be measured by the following parameters, 0 = none (best possible outcome), 1 = mild, 2 = moderate, and 3 = severe (worst possible outcome).
Change from Baseline to Day 85
Change in facial skin hydration
The Corneometry device will be used as a measurement of skin hydration. The values of skin hydration degree is between 0-130 arbitrary units (AU). The higher the value means a better outcome.
Three HydraFacial Syndeo Treatment will be performed 28 days apart at the Pflugerville site.
hree HydraFacial Elite MD Treatment will be performed 28 days apart at the Houston site.
Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin.
The Regen-GF Booster, a serum formulated to increase collagen and elastin production, will be used during each HydraFacial treatment using the HydraFacial handpiece and specialized tip for application. Ingredients include Heptapeptide-32 maintains the appearance of healthy, youthful skin through collagen and elastin production, Copper Peptide Cu-GHK regenerates healthy-looking skin by accelerating wound healing and skin repair, Palmitoyl Tetrapeptide-7 treats inflammation while boosting the growth of collagen-producing tissues, Palmitoyl Tripeptide-5 helps skin cells flush toxins while enhancing the appearance of firmness, Azelaoyl Bis-Dipeptide 10 addresses signs of aging by managing the formation of free radicals, K3 Vitamin C promotes collagen synthesis, and Hyaluronic Acid hydrates the skin.
Austin Institute for Clinical Research, Inc.
Houston, Texas, 77056, United States
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660, United States
Edward Lain, MD, MBA
Austin Institute for Clinical Research
27 participants (actual enrollment reported by the registry).
First Submitted
June 15, 2023
First Posted
July 6, 2023
Study Start
Change from Baseline to Day 85
Change in transepidermal water loss
The Tewlometry device will be used as a measurement of transepidermal water loss. The units of measurement are grams of water per square meter per hour. The higher the value means a better outcome.
Change from Baseline to Day 85
Utilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
Contact the study team to confirm eligibility.
November 20, 2023
Actual (reported)Primary Completion
October 9, 2024
Actual (reported)Study Completion
October 9, 2024
Actual (reported)Last Updated
October 24, 2024
Record last verified: 2024-07
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Source: ClinicalTrials.gov.
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