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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

Tracking Information
First Submitted Date  ICMJE November 18, 2020
First Posted Date  ICMJE November 23, 2020
Last Update Posted Date July 22, 2021
Actual Study Start Date  ICMJE November 25, 2020
Actual Primary Completion Date July 18, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 18, 2021)
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"
Original Primary Outcome Measures  ICMJE Not Provided
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE The Efficacy of the Alma Hybrid System for a New Approach of Facial Skin Treatment
Official Title  ICMJE 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
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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Rejuvenation
Intervention  ICMJE Device: Facial skin treatment
Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths
Study Arms  ICMJE Experimental: Facial skin treatment
Facial skin treatment using the Alma Hybrid system.
Intervention: Device: Facial skin treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 18, 2021)
22
Original Enrollment  ICMJE Not Provided
Actual Study Completion Date  ICMJE July 18, 2021
Actual Primary Completion Date July 18, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 35 Years to 60 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04640207
Other Study ID Numbers  ICMJE ALM-Hyb-Pro-20-011
Has Data Monitoring Committee No
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Alma Lasers
Original Responsible Party [Redacted]
Current Study Sponsor  ICMJE Alma Lasers
Original Study Sponsor  ICMJE [Redacted]
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Thomas Griffin, MD Dermatology Associates of Plymouth Meeting, P.C.
PRS Account Alma Lasers
Verification Date July 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP