AVAVA SR-1 Wrinkles and BPL Study

NCT04925921 | Completed FDA Device

• 1 other identifier: AV-21-003
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Wrinkle; Benign Pigmented Lesion

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (6)

• Reduction of pigmentation in benign pigmented lesions (BPL)

  3 months after the final treatment

• Subject satisfaction with the improvement in wrinkles

  1 and 3 months after the final treatment

• Subject satisfaction with the improvement in BPL

  1 and 3 months after the final treatment

• Tolerance of procedure

  during treatment

• Adverse Events

  3 months after the final treatment

Study Arms (1)

Treatment

EXPERIMENTAL

Treatment with the SR-1 Laser

Device: SR-1 Laser

Interventions

SR-1 Laser DEVICE

3-4 treatments at 4-6 week intervals

Also known as: SR-1 Skin Treatment System

Treatment

Eligibility Criteria

• Age: 22 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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
• Willingness to have both sides of the face exposed to the SR-1 Laser.
• 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.
• Willingness to comply with the following during the study, including the follow-up period:
• maintain consistent skin care regimen on treated areas
• cover treated areas or have very limited sun exposure and use a provided sunscreen as directed by the Investigator
• refrain from using systemic corticosteroids
• refrain from using systemic or topical skin-lightening medications or retinoids
• refrain from any other procedures in the treatment areas
• Willingness and ability to comply with study instructions and return for required visits.

You may not qualify if:

• Skin pathology or condition, or medication use that could interfere with evaluation of the study procedure, e.g.,
• Isotretinoin use within previous 6 months
• Surgical treatment in the target areas within previous 6 months
• Active vitiligo, psoriasis, or eczema, or history of these in the treatment area
• Injection of botulinum toxin in the treatment areas within the previous 3 months.
• 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).
• Current smoker or history of smoking greater than 0.5 pack/day in past 5 years.
• Excessive sun exposure in the previous month, or unable or unlikely to refrain from tanning or excessive sun exposure during the study.
• 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.
• Active localized or systemic infection, or an open wound in area being treated.
• History of abnormal wound healing or abnormal scarring (e.g., hypertrophic or keloid).
• History of connective tissue disease, such as lupus or scleroderma.
• History of seizure disorders due to light.
• 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).
• History of gold therapy.

Sponsors & Collaborators

• AVAVA, Inc.: lead

Study Sites (1)

AVAVA, Inc.

Waltham, Massachusetts, 02451, United States

Location

Related Publications (2)

• 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.

  PMID: 3377516 BACKGROUND

• 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.

  PMID: 8629842 BACKGROUND

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 2, 2021
• First Posted: June 14, 2021
• Study Start: May 10, 2021
• Primary Completion: December 22, 2021
• Study Completion: July 25, 2022
• Last Updated: December 12, 2023

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)