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

NCT04640207 | Completed FDA Device

• 1 other identifier: ALM-Hyb-Pro-20-011
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 1

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.

Conditions

Rejuvenation

Outcome Measures

Primary Outcomes (1)

• Investigator assessment

  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"

  3 month after last treatment

Study Arms (1)

Facial skin treatment

EXPERIMENTAL

Facial skin treatment using the Alma Hybrid system.

Device: Facial skin treatment

Interventions

Facial skin treatment DEVICE

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

Facial skin treatment

Eligibility Criteria

• Age: 35 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Alma Lasers: lead

Study Sites (1)

Dermatology Associates of Plymouth Meeting, P.C.

Plymouth Meeting, Pennsylvania, 19762, United States

Location

Study Officials

• Thomas Griffin, MD

  Dermatology Associates of Plymouth Meeting, P.C.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 18, 2020
• First Posted: November 23, 2020
• Study Start: November 25, 2020
• Primary Completion: July 18, 2021
• Study Completion: July 18, 2021
• Last Updated: July 22, 2021

Record last verified: 2021-07

Locations

US (1)