Skip to main content
OpenTrials
Completed

NCT Number: NCT04640207

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

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.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Rejuvenation

Age range

35 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dermatology Associates of Plymouth Meeting, P.C.

Plymouth Meeting, Pennsylvania, 19762, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Facial skin treatment

Device

Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths

Primary outcomes

  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"

Sponsors and collaborators

Lead sponsor

Alma Lasers

Industry

Registry information

Official study 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

Important dates

Study start
2020
Primary completion
2021
Study completion
2021
First posted
Nov 23, 2020
Registry last updated
Jul 22, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.