RejuvenationNCT04640207
The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment
A study testing Facial skin treatment in people with Rejuvenation, run by Alma Lasers at 1 site in United States.
Trial summary
The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths. The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Rejuvenation
- What is being tested?
- Facial skin treatment
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 1 siteUnited States
- Study dates
- 25 Nov 2020to 18 Jul 2021
- Phase
- Interventional
- 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 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Main Inclusion Criteria:
- Male or Female, 35 to 60 years of age, at the time of enrollment
- Fitzpatrick skin type I-IV
- Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6
Main Exclusion Criteria:
- Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
- Heavy smoker (>1 pack of cigarettes a day)
- Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
- Previous rejuvenation treatments on the same area, such as chemical peel, dermabrasion, non-ablative or ablative resurfacing procedure, or face-lift with laser or other devices, up to 3 months prior to the enrollment
- Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months.
- Prior use of Botox in the treatment area within 5 months
- Infection, dermatitis, rash, or other skin abnormality in the target area
- History of any disease or condition that could impair wound healing
- History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
Trial locations and contacts
1 site in 1 country.
United States1 site
Dermatology Associates of Plymouth Meeting, P.C.
Plymouth Meeting, Pennsylvania, 19762
About this study
Official title: Prospective, Single-Center, Open-Label Study to Evaluate the Efficacy of the Alma Hybrid System for New Approach of Facial Skin Treatment With Minimal Downtime
The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.
The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.
- Conditions
- Rejuvenation
- Being tested
- Facial skin treatment
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Facial skin treatmentDevice
Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths
| Study group | Role | What they receive |
|---|---|---|
| Facial skin treatment | Experimental | Facial skin treatment using the Alma Hybrid system. Receives: Device: Facial skin treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Investigator assessment
Investigator assessment of the overall facial skin aesthetic appearance using a 5 point Likert scale (when "1" indicate "not at all improved" and "5" indicates " very much improved"
Measured: 3 month after last treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2020
- Study start25 Nov 2020
- Primary completion18 Jul 2021
- Study completion18 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for RejuvenationStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Thomas Griffin, MD, Principal investigator, Dermatology Associates of Plymouth Meeting, P.C.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04640207
- Sponsor's protocol ID
- ALM-Hyb-Pro-20-011
- Status last verified
- Jul 2021
- First submitted
- 18 Nov 2020
- Last updated
- 22 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Single-Center, Open-Label Study to Evaluate the Efficacy of the Alma Hybrid System for New Approach of Facial Skin Treatment With Minimal Downtime
- ClinicalTrials.gov ID
- NCT04640207
- Acronym / sponsor ID
- ALM-Hyb-Pro-20-011
- Conditions
- Rejuvenation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 25 Nov 2020 (actual)
- Primary completion
- 18 Jul 2021 (actual)
- Study completion
- 18 Jul 2021 (actual)
- First posted
- 23 Nov 2020 (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.
The study is aimed to evaluate the efficacy of the Alma Hybrid system for a new approach of facial skin treatment, using both ablative and non-ablative wavelengths.
The study will include 20 subjects with mild-moderate photodamaged skin, that will undergo 2 facial skin treatments. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Facial skin treatment | Experimental | Device: Facial skin treatmentFacial skin treatment using the Alma Hybrid system. |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
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 |
|---|---|---|
| Facial skin treatmentFacial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths | Device | Facial skin treatment |
Primary outcome
Investigator assessment
Time frame: 3 month after last treatment
Investigator assessment of the overall facial skin aesthetic appearance using a 5 point Likert scale (when "1" indicate "not at all improved" and "5" indicates " very much improved"
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 22 Jul 2021.
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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.
Thomas Griffin, MD principal investigator
Dermatology Associates of Plymouth Meeting, P.C.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Facial skin treatment in people with Rejuvenation, run by Alma Lasers at 1 site 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?
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 22 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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?
Investigator assessment (time frame: 3 month after last treatment). 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 22 Jul 2021.