An interventional study of Alma Harmony in Facial Skin Wrinkles, sponsored by Alma Lasers. Not yet recruiting at 1 site in Albania. Open to female participants aged 35 Years to 55 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-05.
Sponsored by Alma Lasers (part of Fosun Pharma) · Not applicable, Interventional, and Treatment
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
Alma Lasers is the lead sponsor of 8 studies on the registry; 2 are open to participants now.
First submitted after Alma Lasers became part of Fosun Pharma.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Autoimmune disease
A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.
Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Treatment of facial skin wrinkles using the Alma Harmony platform with the ClearLift high power Q-switched (QS) 1064nm Nd:YAG laser module
Device: Alma Harmony
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.
Also known as: ClearLift applicator
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".
Time frame: at the 3-month follow-up
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".
Time frame: 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
Time frame: 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 ".
Time frame: at the 1 and 3-month follow-up
Safety & Tolerability
At the beginning of each visit starting the second treatment visit, the investigator will record the occurrence of adverse events (such as prolonged Erythema/ Edema, Burns, Hematoma / Ecchymosis, Scarring, and Hyperpigmentation.) and will rate their severity according to a 3 points scale in which 1= mild; 2= moderate, and 3=severe.
Time frame: throughout the study
Safety & Tolerability
Pain level using a 11- points Numerical Pain Rating Scale (NPRS) in which 0= "No pain" and 10="Worst possible pain", as evaluated at each treatment visit at the end of each treatment session.
Time frame: immediately after each treatment session (up to 1 month)
This study is not yet recruiting, as verified in Mar 2024. You cannot join it, but the record below documents what was studied.
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