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

Rejuvenation Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04640207
• Other study ID #: ALM-Hyb-Pro-20-011
• Status: Completed
• Phase: N/A
• Start date: November 25, 2020
• Est. completion date: July 18, 2021

Study information

• Verified date: July 2021
• Source: Alma Lasers
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 22
• Est. completion date: July 18, 2021
• Est. primary completion date: July 18, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 35 Years to 60 Years

Eligibility

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

Related Conditions & MeSH terms

• Rejuvenation

Intervention

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

Locations

Country	Name	City	State
United States	Dermatology Associates of Plymouth Meeting, P.C.	Plymouth Meeting	Pennsylvania

Sponsors (1)

Lead Sponsor	Collaborator
Alma Lasers

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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