Facial Skin WrinklesNCT06349096
Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles
A study testing Alma Harmony in people with Facial Skin Wrinkles, run by Alma Lasers at 1 site in Albania.
Trial summary
Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. Read more about this study
- Who is it for?
- Ages 35 to 55 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Facial Skin Wrinkles
- What is being tested?
- Alma Harmony
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteAlbania
- Study dates
- 26 Mar 2024to Oct 2024
- 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 55 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects aged ≥ 35 and ≤ 55 years
- Presence of type 1-3 facial skin wrinkles, according to the Glogau scale;
- Subjects in reasonably good general health, according to Investigator's judgment;
- Subjects who agree to avoid tanning during the entire investigational period;
- Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal or application of any cosmoceutical/pharmaceutical without the consent from the PI only.
- Subjects able to understand the full nature and the purpose of the investigation, including possible risks and side effects, able to cooperate with the Investigator and to comply with the requirements of the entire investigation (ability to attend all the planned investigation visits according to the time limits included) based on Investigator's judgement.
- Subjects willing to sign an informed consent, consent to use their photos for future scientific or marketing purposes, according to the sponsor's needs.
Who cannot join
- Subjects with active infections;
- Subjects with history of keloid scarring or hypertrophic scar formation;
- Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months;
- Subjects who have been tanning within the past 30 days;
- Previous surgical treatment of the area selected for the treatment with the investigational device;
- Subjects with any inflammatory skin condition e.g., eczema, active herpes simplex, etc. at the treatment site;
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- Subjects with presence of tattoos at the treatment site;
- Subjects with skin cancer or any other cancer and/or any cancer drug therapy (such as ducabaxine, fluorouracil, methotrexate, etc.);
- Subjects with history of autoimmune disorder or evidence of immunosuppression;
- Subjects with cellulitis;
- Subjects with collagen vascular diseases;
- Subjects with thrombocytopenia;
- Subjects with peripheral vascular disease;
- Subjects with Melasma;
- Pregnant or lactating subjects.
Trial locations and contacts
1 site in 1 country.
Albania1 site
San Luca Medical Clinic
Tirana
Arminda Avdulaj, MD, 694488000 ext. +355, avdulajarminda@gmail.com
Arminda Avdulaj, MD
About this study
Official title: Open-Label, Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles
Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.
Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles
- Conditions
- Facial Skin Wrinkles
- Being tested
- Alma Harmony
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Alma HarmonyDevice
Also called ClearLift applicator
The ClearLift is a class IIb medical device, High Power Q-switched (QS) 1064nm Nd:YAG laser module in the Harmony system. It has a targeted laser module for the non-invasive removal of various colored tattoos, as well as deep and superficial benign pigmented lesions, wrinkles, fine lines, and skin tightening.
| Study group | Role | What they receive |
|---|---|---|
| Laser treatment | Experimental | Treatment of facial skin wrinkles using the Alma Harmony platform with the ClearLift high power Q-switched (QS) 1064nm Nd:YAG laser module Receives: Device: Alma Harmony |
What is being measured
The primary outcome is the main question the study is designed to answer.
Primary endpoint
70% of participants will demonstrate any improvement in the treated facial skin wrinkles after ClearLift treatment based on the rating of three blinded assessors that will compare the baseline 2D photographs with the 3-month follow-up visit photographs and will rate the degree of improvement using the 5-points Global Aesthetic Improvement Scale (GAIS)- in which 1 denotes "Wors";2 denotes "No change";3 denotes "Improved"; 4 denotes "Much improved"; and 5 denotes "Very much improved".
Measured: at the 3-month follow-up
Secondary outcomes (3)
Secondary endpoint
Improvement in the treated facial skin wrinkles after ClearLift treatment based on the rating of the investigator that will compare the baseline 2D photographs with the 1-month follow-up visit photographs and will rate the degree of improvement using the 5-points Global Aesthetic Improvement Scale (GAIS)- in which 1 denotes "Wors";2 denotes "No change";3 denotes "Improved"; 4 denotes "Much improved"; and 5 denotes "Very much improved".
Measured: at the 1-month follow-up
Secondary endpoint
Improvement in skin texture of the treated facial skin wrinkles, as evaluated by the VISIA 3D camera, at the 1- and 3-month follow-up visits compared to baseline
Measured: at the 1 and 3-month follow-up
Secondary endpoint
Participant's satisfaction with treatment at the 1- and 3-month follow-up visits, as evaluated using a 5-point Likert scale, in which 1 denotes "Very dissatisfied";2 denotes "Dissatisfied";3 denotes "Satisfied"; 4 denotes "Very satisfied"; and 5 denotes "Extremely satisfied ".
Measured: at the 1 and 3-month follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Apr 2024
- Study start26 Mar 2024 (estimated)
- Primary completionOct 2024 (estimated)
- Study completionOct 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Facial Skin WrinklesStudies 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
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alma Lasers
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Arminda Avdulaj, MD, Principal investigator, Head of San Luca Medical Clinic, Tirana, Albania
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06349096
- Sponsor's protocol ID
- ALM-HAR-CLL-23-01
- Status last verified
- Mar 2024
- First submitted
- 21 Mar 2024
- Last updated
- 5 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label, Safety And Efficacy Investigation Of The Effects Of ClearLift Q-Switched Nd:Yag 1064nm Laser Module In The Treatment Of Facial Skin Wrinkles
- ClinicalTrials.gov ID
- NCT06349096
- Acronym / sponsor ID
- ALM-HAR-CLL-23-01
- Conditions
- Facial Skin Wrinkles
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Alma LasersIndustry (pharma, biotech, devices)
- Study start
- 26 Mar 2024 (estimated)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Oct 2024 (estimated)
- First posted
- 5 Apr 2024 (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.
Alma Lasers ClearLift is a fractional non-ablative Q-Switched laser, allowing practitioners to use the benefits of a high intensity QS laser for the treatment of aged skin. Alma Harmony ClearLift uses a fractional QS laser to achieve a deep mechanical effect beneath the epidermis via a photoacustic effect. This creates a controlled dermal wound while leaving the epidermis intact. The wound healing process stimulates growth of new collagen, skin contracture and tightening. This procedure is virtually painless with no downtime and is safe for all skin types.
Based on this background, we have considered an interest to design a study aimed at assessing the efficacy and safety of a treatment course with ClearLift Module in patients with facial skin wrinkles
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Laser treatment | Experimental | Device: Alma HarmonyTreatment of facial skin wrinkles using the Alma Harmony platform with the ClearLift high power Q-switched (QS) 1064nm Nd:YAG laser module |
Who may qualify
- Ages
- 35 to 55 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Female subjects aged ≥ 35 and ≤ 55 years
- Presence of type 1-3 facial skin wrinkles, according to the Glogau scale;
- Subjects in reasonably good general health, according to Investigator's judgment;
- Subjects who agree to avoid tanning during the entire investigational period;
- Subjects who agree to avoid any other facial procedure during the entire investigational period; including but not limited to: injectables or threads, peeling of any kind, dermabrasion, facial hair removal or application of any cosmoceutical/pharmaceutical without the consent from the PI only.
Key exclusion criteria (15 listed)
- Subjects with active infections;
- Subjects with history of keloid scarring or hypertrophic scar formation;
- Subjects with previous medical treatment of the area, or oral retinoid drug prescribed within the past six months;
- Subjects who have been tanning within the past 30 days;
- Previous surgical treatment of the area selected for the treatment with the investigational device;
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 |
|---|---|---|
| Alma HarmonyAlso: ClearLift applicatorThe ClearLift is a class IIb medical device, High Power Q-switched (QS) 1064nm Nd:YAG laser module in the Harmony system. It has a targeted laser module for the non-invasive removal of various colored tattoos, as well as deep and superficial benign pigmented lesions, wrinkles, fine lines, and skin tightening. | Device | Laser treatment |
Primary outcome
Primary endpoint
Time frame: at the 3-month follow-up
70% of participants will demonstrate any improvement in the treated facial skin wrinkles after ClearLift treatment based on the rating of three blinded assessors that will compare the baseline 2D photographs with the 3-month follow-up visit photographs and will rate the degree of improvement using the 5-points Global Aesthetic Improvement Scale (GAIS)- in which 1 denotes "Wors";2 denotes "No change";3 denotes "Improved"; 4 denotes "Much improved"; and 5 denotes "Very much improved".
3 secondary outcomes
Secondary endpoint
Time frame: at the 1-month follow-up
Secondary endpoint
Time frame: at the 1 and 3-month follow-up
Secondary endpoint
Time frame: at the 1 and 3-month follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2024.
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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.
Arminda Avdulaj, MD principal investigator
Head of San Luca Medical Clinic, Tirana, Albania
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Alma Harmony in people with Facial Skin Wrinkles, run by Alma Lasers at 1 site in Albania.
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 7 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 5 Apr 2024. 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 Albania. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shir Bekerman, BSC,MBA (522906172 ext. +972, shir.bekerman@almalasers.co.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Primary endpoint (time frame: at the 3-month follow-up). 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 5 Apr 2024.