Cutis Laxa FacialisPhase 4NCT05932732
Trial Assessing the Impact on Facial Skin Quality, Hydration, and Skin Barrier of Three (3) Hydrafacial Treatments in Adults of All Skin Types.
A Phase 4 study testing HydraFacial Syndeo System, ReGen-GF and HydraFacial Elite MD System in people with Cutis Laxa Facialis and Xeroderma, run by Austin Institute for Clinical Research at 2 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Cutis Laxa Facialis, Xeroderma
- What is being tested?
- HydraFacial Syndeo System, ReGen-GF and HydraFacial Elite MD System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesUnited States
- Study dates
- 20 Nov 2023to 9 Oct 2024
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Austin Institute for Clinical Research, Inc.
Houston, Texas, 77056
Austin Institute for Clinical Research, Inc.
Pflugerville, Texas, 78660
About this study
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
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.
Read the 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.
- Conditions
- Cutis Laxa Facialis, Xeroderma
- Being tested
- HydraFacial Syndeo System, ReGen-GF, HydraFacial Elite MD System
- Medical subject headings
- Ichthyosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HydraFacial Syndeo SystemDevice
Utilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin.
ReGen-GFDrug
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 Elite MD SystemDevice
Utilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin.
| Study group | Role | What they receive |
|---|---|---|
| HydraFacial Syndeo Treatment | Other | Three HydraFacial Syndeo Treatment will be performed 28 days apart at the Pflugerville site. Receives: 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. Receives: Drug: ReGen-GF; Device: HydraFacial Elite MD System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: Change from Baseline to Day 85
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jul 2023
- Study start20 Nov 2023
- Primary completion9 Oct 2024
- Study completion9 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cutis Laxa FacialisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- 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)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Austin Institute for Clinical Research
- Sponsor type
- Research network
- Collaborators
- The HydraFacial Company
- Responsible party
- Sponsor
- Investigators
- Edward Lain, MD, MBA, Principal investigator, Austin Institute for Clinical Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05932732
- Sponsor's protocol ID
- PDCR-000300
- Status last verified
- Jul 2024
- First submitted
- 15 Jun 2023
- Last updated
- 24 Oct 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05932732
- Acronym / sponsor ID
- PDCR-000300
- Conditions
- Cutis Laxa Facialis, Xeroderma
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Austin Institute for Clinical ResearchResearch network
- Collaborators
- The HydraFacial Company
- Study start
- 20 Nov 2023 (actual)
- Primary completion
- 9 Oct 2024 (actual)
- Study completion
- 9 Oct 2024 (actual)
- First posted
- 6 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 2
- 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.
| Arm | Type | Receives |
|---|---|---|
| HydraFacial Syndeo Treatment | Other | Device: HydraFacial Syndeo System, Drug: ReGen-GFThree HydraFacial Syndeo Treatment will be performed 28 days apart at the Pflugerville site. |
| Hydrafacial Elite MD Treatment | Other | Drug: ReGen-GF, Device: HydraFacial Elite MD Systemhree HydraFacial Elite MD Treatment will be performed 28 days apart at the Houston site. |
Who may qualify
- Ages
- 30 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HydraFacial Syndeo SystemUtilizing patented Vortex Fusion Technology, a pneumatic device, the HydraFacial Syndeo system cleanses, exfoliates, and hydrates the skin. | Device | HydraFacial Syndeo Treatment |
| ReGen-GFThe 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. | Drug | HydraFacial Syndeo Treatment, Hydrafacial Elite MD Treatment |
| HydraFacial Elite MD SystemUtilizing patented Vortex Fusion Technology, the HydraFacial Elite MD system cleanses, exfoliates, and hydrates the skin. | Device | Hydrafacial Elite MD Treatment |
Primary outcome
Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size
Time frame: Change from Baseline to Day 85
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
Time frame: Change from Baseline to Day 85
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
Time frame: Change from Baseline to Day 85
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
Time frame: Change from Baseline to Day 85
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
Time frame: Change from Baseline to Day 85
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Oct 2024.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Edward Lain, MD, MBA principal investigator
Austin Institute for Clinical Research
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing HydraFacial Syndeo System, ReGen-GF and HydraFacial Elite MD System in people with Cutis Laxa Facialis and Xeroderma, run by Austin Institute for Clinical Research at 2 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in skin facial skin elasticity, wrinkles, roughness, fine lines, pigmentation, erythema, and pore size (time frame: Change from Baseline to Day 85). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Oct 2024.