Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
20 participants
INTERVENTIONAL
2021-05-10
2022-07-25
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Treatment
Treatment with the SR-1 Laser
SR-1 Laser
3-4 treatments at 4-6 week intervals
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
SR-1 Laser
3-4 treatments at 4-6 week intervals
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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. 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.
22 Years
70 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
AVAVA, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
AVAVA, Inc.
Waltham, Massachusetts, United States
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
AV-21-003
Identifier Type: -
Identifier Source: org_study_id