Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydrafacial Treatments in Adults of All Skin Types.

NCT05932732 | Completed Phase 4 DMC FDA Drug FDA Device

• 1 other identifier: PDCR-000300
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

Brief Summary

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.

Conditions

Cutis Laxa Facialis; Xeroderma

Outcome Measures

Primary Outcomes (5)

• 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.

  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

Study Arms (2)

HydraFacial Syndeo Treatment

OTHER

Three HydraFacial Syndeo Treatment will be performed 28 days apart at the Pflugerville site.

Device: HydraFacial Syndeo System; Drug: ReGen-GF

Hydrafacial Elite MD Treatment

OTHER

hree HydraFacial Elite MD Treatment will be performed 28 days apart at the Houston site.

Drug: ReGen-GF; Device: HydraFacial Elite MD System

Interventions

HydraFacial Syndeo System DEVICE

Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin.

HydraFacial Syndeo Treatment

ReGen-GF DRUG

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.

HydraFacial Syndeo Treatment; Hydrafacial Elite MD Treatment

HydraFacial Elite MD System DEVICE

Utilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin.

Hydrafacial Elite MD Treatment

Eligibility Criteria

• Age: 30 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Healthy males and females of Fitzpatrick skin types I-VI 30-55 years of age.
• No known medical conditions that in the investigator's opinion may interfere with study participation.
• Agrees to abstain from starting a new skincare product for the duration of trial participation.
• Willingness to cooperate and participate by following study requirements.
• Individuals must sign an informed consent and photography consent.

You may not qualify if:

• History of any cancer excluding fully treated basal cell carcinoma or squamous cell carcinoma in situ in the treatment area.
• Presence of untreated precancerous lesions in the treatment area.
• Presence of sunburn, moderate to pronounced suntan, uneven skin tone, tattoos, scars or other disfiguration in the treatment area.
• 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.
• Subject is pregnant, nursing, or planning to become pregnant.
• 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.
• Currently participating in another clinical trial.
• History of Photo Epilepsy.

Sponsors & Collaborators

• Austin Institute for Clinical Research: lead
• The HydraFacial Company: collaborator

Study Sites (2)

Austin Institute for Clinical Research, Inc.

Houston, Texas, 77056, United States

Location

Austin Institute for Clinical Research, Inc.

Pflugerville, Texas, 78660, United States

Location

MeSH Terms

Conditions

Ichthyosis

Condition Hierarchy (Ancestors)

Skin Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Infant, Newborn, Diseases; Keratosis; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Edward Lain, MD, MBA

  Austin Institute for Clinical Research

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Masking Details: Not applicable, no masking.
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: June 15, 2023
• First Posted: July 6, 2023
• Study Start: November 20, 2023
• Primary Completion: October 9, 2024
• Study Completion: October 9, 2024
• Last Updated: October 24, 2024

Record last verified: 2024-07

Locations

US (2)