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

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT04640207

Enrollment

Registered

2020-11-23

Start date

2020-11-25

Completion date

2021-07-18

Last updated

2021-07-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Rejuvenation

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.

Interventions

DEVICEFacial skin treatment

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

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

35 Years to 60 Years

Healthy volunteers

Yes

Inclusion 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

Design outcomes

Primary

Measure	Time frame	Description
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

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026