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

Alma Lasers

Status: Completed

Conditions: Rejuvenation

Treatments: Device: Facial skin treatment

Study type: Interventional

Funder types: Industry

Identifiers

NCT04640207

ALM-Hyb-Pro-20-011

Details and patient eligibility

About

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.

Enrollment: 22 patients

Sex: All

Ages: 35 to 60 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 1 patient group

Facial skin treatment

Experimental group

Description:

Facial skin treatment using the Alma Hybrid system.

Treatment:

Device: Facial skin treatment