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

Not Applicable

Completed

• Conditions: Rejuvenation
• Interventions: Device: Facial skin treatment

• Registration Number: NCT04640207
• Lead Sponsor: Alma Lasers

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 available

Study Timeline

• Study First Submitted: 2020-11-18
• Study First Submitted QC: 2020-11-18
• Study First Posted: 2020-11-23
• Study Start: 2020-11-25
• Status Verified: 2021-07
• Primary Completion: 2021-07-18
• Study Completion: 2021-07-18
• Last Update Submitted: 2021-07-18
• Last Update Posted: 2021-07-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 22

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Facial skin treatment	Facial skin treatment	Facial skin treatment using the Alma Hybrid system.

Primary Outcome Measures

Name	Time	Method
Investigator assessment	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"

Trial Locations

Locations (1)

Dermatology Associates of Plymouth Meeting, P.C.; 🇺🇸 Plymouth Meeting, Pennsylvania, United States