WrinkleNCT04925921
AVAVA SR-1 Wrinkles and BPL Study
A study testing SR-1 Laser in people with Wrinkle and Benign Pigmented Lesion, run by AVAVA, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 22 to 70 years
- Conditions the study is for
- Wrinkle, Benign Pigmented Lesion
- What is being tested?
- SR-1 Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 10 May 2021to 25 Jul 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 22 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
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- 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.
- 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.
- History of radiation to the treatment area or undergoing systemic chemotherapy for the treatment of cancer. Current cancerous lesion in the treatment area.
- Pregnancy or lactation, or intent to become pregnant within the study period.
- Significant uncontrolled concurrent illness, such as diabetes mellitus, hypertension, or cardiovascular disease.
- History of immunosuppression/immune deficiency disorder or currently using immunosuppressive medications.
- Planned weight loss of greater than five pounds.
- Facial hair in the treatment areas which would prevent evaluation of the outcome measures.
- 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.
- 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.
Trial locations and contacts
1 site in 1 country.
About this 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.
- Conditions
- Wrinkle, Benign Pigmented Lesion
- Being tested
- SR-1 Laser
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SR-1 LaserDevice
Also called SR-1 Skin Treatment System
3-4 treatments at 4-6 week intervals
| Study group | Role | What they receive |
|---|---|---|
| Treatment | Experimental | Treatment with the SR-1 Laser Receives: Device: SR-1 Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 3 months after the final treatment
Secondary outcomes (6)
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.
Measured: 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".
Measured: 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".
Measured: 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.
Measured: during treatment
Adverse Events
The incidence and severity of adverse events
Measured: 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".
Measured: 1 and 3 months after the final treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start10 May 2021
- Primary completion22 Dec 2021
- Study completion25 Jul 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for WrinkleStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- AVAVA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04925921
- Sponsor's protocol ID
- AV-21-003
- Status last verified
- Dec 2023
- First submitted
- 2 Jun 2021
- Last updated
- 12 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
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.
PubMed 3377516Fitzpatrick 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.
PubMed 8629842
Study at a glance
From the registry record, last updated by the sponsor on 12 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVAVA SR-1 Wrinkles and BPL Study
- ClinicalTrials.gov ID
- NCT04925921
- Acronym / sponsor ID
- AV-21-003
- Conditions
- Wrinkle, Benign Pigmented Lesion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- AVAVA, Inc.Industry (pharma, biotech, devices)
- Study start
- 10 May 2021 (actual)
- Primary completion
- 22 Dec 2021 (actual)
- Study completion
- 25 Jul 2022 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment | Experimental | Device: SR-1 LaserTreatment with the SR-1 Laser |
Who may qualify
- Ages
- 22 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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:
- Willingness and ability to comply with study instructions and return for required visits.
Key exclusion criteria (24 listed)
- Skin pathology or condition, or medication use that could interfere with evaluation of the study procedure, e.g.,
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SR-1 LaserAlso: SR-1 Skin Treatment System3-4 treatments at 4-6 week intervals | Device | Treatment |
Primary outcome
Improvement in facial wrinkles
Time frame: 3 months after the final treatment
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.
6 secondary outcomes
Reduction of pigmentation in benign pigmented lesions (BPL)
Time frame: 3 months after the final treatment
Subject satisfaction with the improvement in wrinkles
Time frame: 1 and 3 months after the final treatment
Subject satisfaction with the improvement in BPL
Time frame: 1 and 3 months after the final treatment
Tolerance of procedure
Time frame: during treatment
Adverse Events
Time frame: 3 months after the final treatment
Overall improvement
Time frame: 1 and 3 months after the final treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Dec 2023.
- Background: PubMed 3377516Fitzpatrick 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.
- Background: PubMed 8629842Fitzpatrick 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SR-1 Laser in people with Wrinkle and Benign Pigmented Lesion, run by AVAVA, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 24 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 12 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Improvement in facial wrinkles (time frame: 3 months after the final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04925921, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Dec 2023.