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

Primary Purpose

Cutis Laxa Facialis, Xeroderma

Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
HydraFacial Syndeo System
ReGen-GF
HydraFacial Elite MD System
Sponsored by
Austin Institute for Clinical Research
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cutis Laxa Facialis

Eligibility Criteria

30 Years - 55 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria: 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. Exclusion Criteria: 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.

Sites / Locations

  • Austin Institute for Clinical Research, Inc.
  • Austin Institute for Clinical Research, Inc.

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

HydraFacial Syndeo Treatment

Hydrafacial Elite MD Treatment

Arm Description

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.

Outcomes

Primary Outcome Measures

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 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 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 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 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.

Secondary Outcome Measures

Full Information

First Posted
June 15, 2023
Last Updated
October 13, 2023
Sponsor
Austin Institute for Clinical Research
Collaborators
The HydraFacial Company
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1. Study Identification

Unique Protocol Identification Number
NCT05932732
Brief Title
Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydrafacial Treatments in Adults of All Skin Types.
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
December 2023 (Anticipated)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Austin Institute for Clinical Research
Collaborators
The HydraFacial Company

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
Yes

5. Study Description

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.
Detailed Description
A multisite study. Approximately 30 subjects will be enrolled in the trail. The purpose of this study is to assess the changes in facial skin hydration and moisturization after a series of 3 hydrafacial treatments in subjects of all Fitzpatrick skin types. In addition, patient and investigator assessed changes in skin quality characteristics will be captured. The primary object is Improvement in skin quality assessments performed by the investigator from baseline (prior to treatment 1) to Day 85, the final study visit. Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system and HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin. The procedure lasts 30-45 minutes and includes three steps: a gentle cleansing, followed by a light peel and then infusion of a proprietary blend of ingredients, termed the Regen GF booster, which contains growth factors, humectants and moisturizers. Once this treatment is complete subjects will undergo a non-invasive red LED treatment, Ellipse Red Light, during which the skin is exposed to gentle red light under a horseshoe-shaped illumination device while wearing blocking goggles, to improve circulation and reduce inflammation. The first visit, including screening and baseline with HF treatment #1, is followed by two additional HF treatments 28 days apart, with a final visit occurring on day 85. PROs, including satisfaction are captured, as well as Investigator-assessed measurements of skin quality (using the validated Scientific Assessment Scale of Skin Quality) including elasticity, roughness, fine lines, pigmentation, erythema, and pore size, Investigator Global Aesthetic Improvement Scale, and Investigator Tolerability Assessment. Additionally, corneometry (a measurement of skin hydration) and tewlometry (a measure of transepidermal water loss, assessing the integrity of the skin barrier) are performed to assess changes with the treatments at selected time points. All adverse events observed by the study site personnel, or reported spontaneously by the subject, will be recorded, including description, assessment of severity, and relationship to study treatment. Study site will document all serious adverse events that occur (whether or not related to study treatment). The collection period for all SAEs will begin after informed consent is obtained and end after procedures for the final study visit have been completed. The site investigator will report SAEs in accordance with the standard operating procedures and policies of the local Institutional Review Board (IRB). Subjects are free to withdraw from participating in this study at any time and for whatever reason, specified or unspecified, and without prejudice. Subjects who terminate early will be asked to complete, if possible, all assessments and procedures that would have been conducted on the last study visit. It is the responsibility of the site investigator to identify and report deviations within 5 working days of identification of the protocol deviation. All deviations must be addressed in study source documents, reported to the study sponsor, and the reviewing Institutional Review Board (IRB) per their policies. This is an exploratory study for which results will be reported, but not analyzed with statistical tools beyond calculating mean values. No interim analyses will be conducted. This study will use web-based, electronic case report forms (eCRFs) developed through a validated, Electronic Records/Electronic Signatures-compliant platform (US Title 21 CFR Part 11). The Investigator is responsible for all data entered via the remote data capture (RDC) system from the eCRFs and must confirm the accuracy of the data by electronically approving (signing) the eCRFs. The Sponsor will review the database to identify data errors or inconsistencies, which will be posted in the RDC system as queries for resolution.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cutis Laxa Facialis, Xeroderma

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
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.
Masking
None (Open Label)
Masking Description
Not applicable, no masking.
Allocation
Non-Randomized
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
HydraFacial Syndeo Treatment
Arm Type
Other
Arm Description
Three HydraFacial Syndeo Treatment will be performed 28 days apart at the Pflugerville site.
Arm Title
Hydrafacial Elite MD Treatment
Arm Type
Other
Arm Description
hree HydraFacial Elite MD Treatment will be performed 28 days apart at the Houston site.
Intervention Type
Device
Intervention Name(s)
HydraFacial Syndeo System
Intervention Description
Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin.
Intervention Type
Drug
Intervention Name(s)
ReGen-GF
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
HydraFacial Elite MD System
Intervention Description
Utilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin.
Primary Outcome Measure Information:
Title
Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size
Description
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).
Time Frame
Change from Baseline to Day 85
Title
Change in facial aesthetic appearance
Description
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).
Time Frame
Change from Baseline to Day 85
Title
Change in subjective irritation parameters
Description
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).
Time Frame
Change from Baseline to Day 85
Title
Change in facial skin hydration
Description
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.
Time Frame
Change from Baseline to Day 85
Title
Change in transepidermal water loss
Description
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.
Time Frame
Change from Baseline to Day 85

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Celeste Brigham, BAAS
Phone
5122792545
Ext
783
Email
iitcoordinator@atxresearch.com
First Name & Middle Initial & Last Name or Official Title & Degree
Celeste Katona, BA
Phone
5122792545
Ext
772
Email
ckatona@atxresearch.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Edward Lain, MD, MBA
Organizational Affiliation
Austin Institute for Clinical Research
Official's Role
Principal Investigator
Facility Information:
Facility Name
Austin Institute for Clinical Research, Inc.
City
Houston
State/Province
Texas
ZIP/Postal Code
77056
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celeste Brigham, BAAS
Phone
512-270-2545
Ext
783
Email
iitcoordinator@atxresearch.com
First Name & Middle Initial & Last Name & Degree
Celeste Katona, BA
Phone
512-279-2545
Ext
772
Email
ckatona@atxresearch.com
First Name & Middle Initial & Last Name & Degree
Megan Couvillion, MD
First Name & Middle Initial & Last Name & Degree
Helyn Alvarez, MD
Facility Name
Austin Institute for Clinical Research, Inc.
City
Pflugerville
State/Province
Texas
ZIP/Postal Code
78660
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Celeste Brigham, BAAS
Phone
512-270-2545
Ext
783
Email
iitcoordinator@atxresearch.com
First Name & Middle Initial & Last Name & Degree
Celeste Katona, BA
Phone
5122792545
Ext
772
Email
ckatona@atxresearch.com
First Name & Middle Initial & Last Name & Degree
Edward L Lain, MD, MBA
First Name & Middle Initial & Last Name & Degree
Diana Reyes, PA-C
First Name & Middle Initial & Last Name & Degree
Jennifer J Jordan, PA-C
First Name & Middle Initial & Last Name & Degree
Jennifer Vickers, MD

12. IPD Sharing Statement

Learn more about this trial

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

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