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

• Sponsor: Alma Lasers (Industry)
• Overall Status: Completed
• CT.gov ID: NCT04640207
• Collaborator: (none)
• Enrollment: 22
• Location: 1
• Arm: 1
• Actual Duration (Months): 7.7
• Patients Per Site Per Month: 2.8

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Rejuvenation	Device: Facial skin treatment	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 22 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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
• Actual Study Start Date: Nov 25, 2020
• Actual Primary Completion Date: Jul 18, 2021
• Actual Study Completion Date: Jul 18, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Facial skin treatment Facial skin treatment using the Alma Hybrid system.	Device: Facial skin treatment; Facial skin treatment using the Alma Hybrid system with a unique pattern that includes both ablative and non-ablative wavelengths

Outcome Measures

Primary Outcome Measures

1. 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"

Eligibility Criteria

Criteria

• Ages Eligible for Study: 35 Years to 60 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: Yes

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Dermatology Associates of Plymouth Meeting, P.C.	Plymouth Meeting	Pennsylvania	United States	19762

Sponsors and Collaborators

• Alma Lasers

Investigators

• Principal Investigator: Thomas Griffin, MD, Dermatology Associates of Plymouth Meeting, P.C.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Alma Lasers
• ClinicalTrials.gov Identifier: NCT04640207
• Other Study ID Numbers: ALM-Hyb-Pro-20-011
• First Posted: Nov 23, 2020
• Last Update Posted: Jul 22, 2021
• Last Verified: Jul 1, 2021

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: Yes
• Product Manufactured in and Exported from the U.S.: No

Study Results

No Results Posted as of Jul 22, 2021