Clinical trial
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
Name
PDCR-000300
Description
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.
Trial arms
Trial start
2023-12-01
Estimated PCD
2024-05-01
Trial end
2024-06-01
Status
Not yet recruiting
Phase
Early phase I
Treatment
HydraFacial Syndeo System
Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin.
Arms:
HydraFacial Syndeo Treatment
ReGen-GF
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.
Arms:
HydraFacial Syndeo Treatment, Hydrafacial Elite MD Treatment
HydraFacial Elite MD System
Utilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin.
Arms:
Hydrafacial Elite MD Treatment
Size
30
Primary endpoint
Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size
Change from Baseline to Day 85
Change in facial aesthetic appearance
Change from Baseline to Day 85
Change in subjective irritation parameters
Change from Baseline to Day 85
Change in facial skin hydration
Change from Baseline to Day 85
Change in transepidermal water loss
Change from Baseline to Day 85
Eligibility criteria
Inclusion Criteria:
1. Healthy males and females of Fitzpatrick skin types I-VI 30-55 years of age.
2. No known medical conditions that in the investigator's opinion may interfere with study participation.
3. Agrees to abstain from starting a new skincare product for the duration of trial participation.
4. Willingness to cooperate and participate by following study requirements.
5. Individuals must sign an informed consent and photography consent.
Exclusion Criteria:
1. History of any cancer excluding fully treated basal cell carcinoma or squamous cell carcinoma in situ in the treatment area.
2. Presence of untreated precancerous lesions in the treatment area.
3. Presence of sunburn, moderate to pronounced suntan, uneven skin tone, tattoos, scars or other disfiguration in the treatment area.
4. Any cutaneous condition that may affect study adherence or ability to assess endpoints, as determined by the investigator, to include, but not limited to, uncontrolled psoriasis, atopic dermatitis, severe photodamage, and uncontrolled acne.
5. Subject is pregnant, nursing, or planning to become pregnant.
6. Significant past medical history of hepatic, hypertensive, renal, cardiac, pulmonary, digestive, hematological, neurological, or psychiatric disease, which in the opinion of the Investigator would compromise the safety of the subject.
7. Currently participating in another clinical trial.
8. History of Photo Epilepsy.
Protocol
{'studyType': 'INTERVENTIONAL', 'phases': ['PHASE4'], 'designInfo': {'allocation': 'NON_RANDOMIZED', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Approximately 5 subjects of each Fitzpatrick skin types I-VI will be included, with a total of 30 subjects participating, assessing efficacy and subject satisfaction, before and after three (3) hydrafacial treatments each performed 28 days apart.', 'primaryPurpose': 'TREATMENT', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Not applicable, no masking.'}}, 'enrollmentInfo': {'count': 30, 'type': 'ESTIMATED'}}
Updated at
2023-10-16
1 organization
1 product
2 indications
Organization
Austin Institute for Clinical ResearchProduct
ReGen-GFIndication
Cutis Laxa FacialisIndication
Xeroderma