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The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04640207
Recruitment Status : Completed
First Posted : November 23, 2020
Last Update Posted : July 22, 2021
Sponsor:
Information provided by (Responsible Party):
Alma Lasers

Study Description
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Brief 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. Follow up visit to evaluate the efficacy of the treatments will take place 1 and 3 months after the last treatment.


Condition or disease Intervention/treatment Phase
Rejuvenation Device: Facial skin treatment Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : November 25, 2020
Actual Primary Completion Date : July 18, 2021
Actual Study Completion Date : July 18, 2021
Arms and Interventions
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Arm Intervention/treatment
Experimental: Facial skin treatment
Facial skin treatment using the Alma Hybrid system.
 Device: Facial skin treatment
Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths


Outcome Measures
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Primary Outcome Measures :
  1. 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"


Eligibility Criteria
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Ages Eligible for Study:   35 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Main Inclusion Criteria:

  1. Male or Female, 35 to 60 years of age, at the time of enrollment
  2. Fitzpatrick skin type I-IV
  3. Mild-moderate photo damages and wrinkles, with Fitzpatrick-Goldman Wrinkle and Elastosis Score of 3-6

Main Exclusion Criteria:

  1. Pregnant, intending to become pregnant during the course of study, less than 3 months postpartum or less than 6 weeks after completion of breastfeeding
  2. Heavy smoker (>1 pack of cigarettes a day)
  3. Unable or unlikely to refrain from tanning, including the use of tanning booths, during the course of the study
  4. 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
  5. Prior use of collagen, fat injections, or other methods of skin augmentation within the past 12 months.
  6. Prior use of Botox in the treatment area within 5 months
  7. Infection, dermatitis, rash, or other skin abnormality in the target area
  8. History of any disease or condition that could impair wound healing
  9. History of keloid formation, hypertrophic scarring, or abnormal/delayed wound healing
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04640207


Locations
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United States, Pennsylvania
Dermatology Associates of Plymouth Meeting, P.C.
Plymouth Meeting, Pennsylvania, United States, 19762
Sponsors and Collaborators
Alma Lasers
Investigators
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Principal Investigator: Thomas Griffin, MD Dermatology Associates of Plymouth Meeting, P.C.
More Information
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Responsible Party: Alma Lasers
ClinicalTrials.gov Identifier: NCT04640207    
Other Study ID Numbers: ALM-Hyb-Pro-20-011
First Posted: November 23, 2020    Key Record Dates
Last Update Posted: July 22, 2021
Last Verified: July 2021

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Product Manufactured in and Exported from the U.S.: No