AVAVA SR-1 Wrinkles and BPL Study

This study is being conducted to evaluate the safety and efficacy of a laser called the SR-1 Skin Treatment System, or SR-1 Laser, for the treatment of wrinkles and pigmented spots. Participants will be treated with the SR-1 Laser 3 or 4 times with each treatment spaced 4-6 weeks apart. The improvement in wrinkles and pigmented spots will be evaluated 1 and 3 months after the final treatment.

Study Overview

• Status: Completed
• Conditions: Wrinkle; Benign Pigmented Lesion
• Intervention / Treatment: Device: SR-1 Laser

• Study Type: Interventional
• Enrollment (Actual): 20
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Waltham, Massachusetts, United States, 02451
      • AVAVA, Inc.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 22 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. Wrinkles on both sides of the face (e.g., peri-oral, peri-orbital, and cheek) scored 4-9 on the Fitzpatrick Wrinkle and Elastosis Scale
2. Willingness to have both sides of the face exposed to the SR-1 Laser.
3. Willingness to have digital photographs taken of their face and agreement with use of photographs, with their identity protected, for presentation, educational, or marketing purposes.

4. Willingness to comply with the following during the study, including the follow-up period:

   1. maintain consistent skin care regimen on treated areas
   2. cover treated areas or have very limited sun exposure and use a provided sunscreen as directed by the Investigator
   3. refrain from using systemic corticosteroids
   4. refrain from using systemic or topical skin-lightening medications or retinoids
   5. refrain from any other procedures in the treatment areas
5. Willingness and ability to comply with study instructions and return for required visits.

Exclusion Criteria:

1. Skin pathology or condition, or medication use that could interfere with evaluation of the study procedure, e.g.,

   1. Isotretinoin use within previous 6 months
   2. Surgical treatment in the target areas within previous 6 months
   3. Active vitiligo, psoriasis, or eczema, or history of these in the treatment area
2. Injection of botulinum toxin in the treatment areas within the previous 3 months.
3. Facial cosmetic procedures in the target areas within previous 6 months (e.g., laser or other energy-based device treatment, microdermabrasion, microneedling, chemical peel, injection of dermal filler).
4. Current smoker or history of smoking greater than 0.5 pack/day in past 5 years.
5. Excessive sun exposure in the previous month, or unable or unlikely to refrain from tanning or excessive sun exposure during the study.
6. Artificial tanning (e.g., tanning bed or tanning lotion/spray) in the target areas within previous 1 month or intention to use artificial tanning during the study.
7. Active localized or systemic infection, or an open wound in area being treated.
8. History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid).
9. History of connective tissue disease, such as lupus or scleroderma.
10. History of seizure disorders due to light.
11. Any use of medication that is known to increase sensitivity to light according to Investigator's discretion (e.g., topicals sensitive to light may be used in other areas off-face).
12. History of gold therapy.
13. History of disease stimulated by heat, such as recurrent herpes simplex or herpes zoster (shingles) in the treatment area, unless treatment is conducted following a prophylactic regimen.
14. History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. Current cancerous lesion in the treatment area.
15. Pregnancy or lactation, or intent to become pregnant within the study period.
16. Significant uncontrolled concurrent illness, such as diabetes mellitus, hypertension, or cardiovascular disease.
17. History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
18. Planned weight loss of greater than five pounds.
19. Facial hair in the treatment areas which would prevent evaluation of the outcome measures.
20. Current enrollment in a clinical study of any other investigational drug or device, or has received an investigational drug or been treated with an investigational device within 6 months prior to entering this study, unless the other clinical study only involves noninvasive imaging.
21. Any other physical or mental condition, or laboratory value, that would, in the professional opinion of the Investigator, potentially affect response or participation in this clinical study, or would pose an unacceptable risk to the subject.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Treatment; Treatment with the SR-1 Laser	Device: SR-1 Laser; 3-4 treatments at 4-6 week intervals; Other Names: SR-1 Skin Treatment System

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Improvement in facial wrinkles	A 1 point or greater reduction in facial wrinkle severity using the Fitzpatrick Wrinkle and Elastosis Scale (FWS), as assessed, and agreed upon by at least two of three blinded independent reviewers in at least 70% of subjects as determined with a side-by-side evaluation of baseline and post-treatment photographs. The FWS scores range from 1 to 9 with lower numbers representing less severe wrinkles.	3 months after the final treatment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Reduction of pigmentation in benign pigmented lesions (BPL)	If clinically identifiable BPL were present at baseline, a greater than 25% reduction in pigmentation of BPL (including, but not limited to, lentigos, solar lentigos, ephelides, and melasma) as assessed, and agreed upon, by at least two of three blinded independent reviewers in at least 50% of subjects as determined with a side-by-side evaluation of baseline and post-treatment photographs.	3 months after the final treatment
Subject satisfaction with the improvement in wrinkles	The percent of subjects satisfied with the improvement in fine lines and wrinkles in the treated areas will be assessed using a Likert scale with responses ranging from "very dissatisfied" to "very satisfied".	1 and 3 months after the final treatment
Subject satisfaction with the improvement in BPL	The percent of subjects satisfied with the improvement in BPL pigmentation will be assessed among subjects with clinically identifiable BPL present at baseline using a Likert scale with responses ranging from "very dissatisfied" to "very satisfied".	1 and 3 months after the final treatment
Tolerance of procedure	Subject tolerance of the procedure based on pain scores during treatment per the 1-10 Visual Analog Scale.	during treatment
Adverse Events	The incidence and severity of adverse events	3 months after the final treatment
Overall improvement	Rate of overall improvement in facial wrinkles and BPL in the treated area(s) as assessed by the investigator using the Global Aesthetic Improvement Scale (GAIS). Wrinkles and BPL will be considered together and one overall score will be created. Scores on the GAIS range from 0 to 4 which correspond to "worsening of conditions", "no improvement in conditions", "mild improvement in conditions", "moderate improvement in conditions", and "significant improvement in conditions".	1 and 3 months after the final treatment

Collaborators and Investigators

• Sponsor: AVAVA, Inc.

Publications and helpful links

General Publications

• Fitzpatrick RE, Goldman MP, Satur NM, Tope WD. Pulsed carbon dioxide laser resurfacing of photo-aged facial skin. Arch Dermatol. 1996 Apr;132(4):395-402.
• Fitzpatrick TB. The validity and practicality of sun-reactive skin types I through VI. Arch Dermatol. 1988 Jun;124(6):869-71. doi: 10.1001/archderm.124.6.869. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): May 10, 2021
• Primary Completion (Actual): December 22, 2021
• Study Completion (Actual): July 25, 2022

Study Registration Dates

• First Submitted: June 2, 2021
• First Submitted That Met QC Criteria: June 8, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Estimated): December 12, 2023
• Last Update Submitted That Met QC Criteria: December 11, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: AV-21-003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• 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