Acne Scars - Mixed Atrophic and HypertrophicMIRIANCT05597267
The MIRIA Acne Scar Study
A study testing MIRIA Laser in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 3 sites in United States.
Trial summary
This study is being conducted to evaluate the performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars. Participants will be treated with the MIRIA laser at least 4 times with each treatment spaced 4-6 weeks apart. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Scars - Mixed Atrophic and Hypertrophic
- What is being tested?
- MIRIA Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 3 sitesUnited States
- Study dates
- 4 Nov 2022to 28 Feb 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Subjects 18-65 years of age
- Acne scars on the face
- Able and willing to comply with all study procedures and at home care; and,
- Able and willing to give informed consent.
Who cannot join
- Hypersensitive to light in the near infrared wavelength region
- On medication known to increase sensitivity to sunlight
- Seizure disorder triggered by light
- Takes or has taken oral isotretinoin, such as Accutane®, within the last six months
- Use of topical over the counter or prescription retinoids such as Retinol creams, gels, Tazarotene, Tretinoin, Adapalene, within the last 30 days
- Active acne or rosacea
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- Active localized or systemic infection, or an open wound or abscess in area being treated
- Significant systemic inflammatory disease or illness, such as lupus, or an illness localized in area being treated
- Common acquired nevi that are predisposed to the development of malignant melanoma
- Current or prior herpes simplex in the target treatment area
- Is receiving or has received gold therapy
- Currently enrolled in an investigational drug or device trial, or has received an investigational drug or was treated with an investigational device within in the area to be treated 6 months prior to study entry
- Facial cosmetic procedures in the target areas within previous 6 months (e.g., laser or other energy-based device treatment, microdermabrasion, injection of dermal filler)
- Micro-needling and/or chemical peel on the target treatment area in the past 3 months
- Injection of cosmetic neurotoxins such as botulinum toxin in the treatment areas within the previous 3 months of standard duration toxins, and 6 months for long lasting neurotoxin therapy
- 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. For men, must be clean shaven in the area of treatment
- Any condition or situation which, in the investigators opinion, may put the subject at significant risk, may confound study results or may interfere significantly with the subject's participation
- Is pregnant or of childbearing potential and not using medically effective birth control, or has been pregnant in the last 3 months, is currently breast feeding or planning a pregnancy during the study.
- Has had unprotected sun exposure within four weeks of treatment, including the use of tanning beds or plans for unprotected sun exposure during the course of the study,
- Has used tanning products, such as creams, lotions and sprays within four weeks prior to treatment.
- Coagulation disorder or currently using anti-platelet/anticoagulation medication, including use of aspirin, or fish oil supplements
- Taking medications that alter the wound-healing response or evidence of compromised wound healing
- Known history of keloid formation
- Known history of medical diseases that may cause koebnerization (the appearance of disease in another location), such as vitiligo, psoriasis or lichen planus
- History of skin cancer or suspicious lesions in treatment area
- Subject is relocating out of the zone of the study site (ie. Moving out of state or about 50+ miles away from study area)
- Subject has history or active melasma or other pigmentary disorders such as vitiligo.
Trial locations and contacts
3 sites in 1 country.
United States3 sites
Enchantress Dermatology
Miami, Florida, 33173
Laser and Skin Surgery Center of New York
New York, New York, 10010
AVAVA, Inc.
Waltham, Massachusetts, 02451
About this study
This study is being conducted to evaluate the performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars. Participants will be treated with the MIRIA laser at least 4 times with each treatment spaced 4-6 weeks apart. The improvement of acne scars will be evaluated at 1 month and 3 months with a possibility of 6 months evaluation after the fourth treatment.
- Being tested
- MIRIA Laser
- Keywords
- Laser Treatment, Acne Scars, MIRIA Laser, Laser, AVAVA, All Skin Types, Scars
- Medical subject headings
- Hypertrophy, Cicatrix
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MIRIA LaserDevice
4-6 experimental treatments at 4-6 weeks intervals
| Study group | Role | What they receive |
|---|---|---|
| Treatment with the MIRIA Laser | Experimental | 3-4 experimental treatments at 4-6 week intervals Receives: Device: MIRIA Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score
ECCA Global Score Limits: Lowest Score (0) to Highest Score (540)
Measured: 3 months after the final treatment, Optional 6 months after final treatment
Secondary outcomes (3)
Blinded Evaluation of Treatment Imaging
Panel of independent expert grader dermatologists will review randomized photo sets of pre- and post-treatment imaging and asked to identify the post-treatment image.
Measured: From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment
Physician Global Aesthetic Improvement Scale Scoring
Primary physician for the investigative site will review post-treatment imaging and score the improvement seen in the photos based on the below scale.
5 - Much Improved 4 - Improved 3 - No Change 2 - Worse
1 - Much Worse
Measured: Up to 3 months after the final treatment, Optional up to 6 months after final treatment
Treatment Pain Assessment
Treatment Pain will be assessed at all treatment visits on a standard Visual Analog Scale Ranging from a score of 0 (no pain) to 10 (maximum possible pain)
Measured: Through study completion, an average of 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Oct 2022
- Study start4 Nov 2022
- Primary completion28 Feb 2025 (estimated)
- Study completion28 Feb 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne Scars - Mixed Atrophic and HypertrophicStudies 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
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AVAVA, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05597267
- Sponsor's protocol ID
- AV-22-002
- Acronym
- MIRIA
- Status last verified
- Mar 2025
- First submitted
- 24 Oct 2022
- Last updated
- 7 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Data is not currently being planned for sharing.
Study at a glance
From the registry record, last updated by the sponsor on 7 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The MIRIA Acne Scar Study
- ClinicalTrials.gov ID
- NCT05597267
- Acronym / sponsor ID
- MIRIA / AV-22-002
- Keywords
- Laser Treatment, Acne Scars, MIRIA Laser, Laser, AVAVA, All Skin Types, Scars
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- AVAVA, Inc.Industry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 28 Feb 2025 (estimated)
- Study completion
- 28 Feb 2025 (estimated)
- First posted
- 28 Oct 2022 (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 performance and efficacy of the AVAVA MIRIA Laser Skin System treatment on acne scars. Participants will be treated with the MIRIA laser at least 4 times with each treatment spaced 4-6 weeks apart. The improvement of acne scars will be evaluated at 1 month and 3 months with a possibility of 6 months evaluation after the fourth 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 with the MIRIA Laser | Experimental | Device: MIRIA Laser3-4 experimental treatments at 4-6 week intervals |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Subjects 18-65 years of age
- Acne scars on the face
- Able and willing to comply with all study procedures and at home care; and,
- Able and willing to give informed consent.
Key exclusion criteria (30 listed)
- Hypersensitive to light in the near infrared wavelength region
- On medication known to increase sensitivity to sunlight
- Seizure disorder triggered by light
- Takes or has taken oral isotretinoin, such as Accutane®, within the last six months
- Use of topical over the counter or prescription retinoids such as Retinol creams, gels, Tazarotene, Tretinoin, Adapalene, within the last 30 days
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 |
|---|---|---|
| MIRIA Laser4-6 experimental treatments at 4-6 weeks intervals | Device | Treatment with the MIRIA Laser |
Primary outcome
ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading
Time frame: 3 months after the final treatment, Optional 6 months after final treatment
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score ECCA Global Score Limits: Lowest Score (0) to Highest Score (540)
3 secondary outcomes
Blinded Evaluation of Treatment Imaging
Time frame: From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment
Physician Global Aesthetic Improvement Scale Scoring
Time frame: Up to 3 months after the final treatment, Optional up to 6 months after final treatment
Treatment Pain Assessment
Time frame: Through study completion, an average of 12 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Mar 2025.
- Individual participant dataSharing planned: No. Data is not currently being planned for sharing.
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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.
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MIRIA Laser in people with Acne Scars - Mixed Atrophic and Hypertrophic, run by AVAVA, Inc. at 3 sites 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 4 inclusion and 30 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: under way, not looking for participants, as of the sponsor's last update on 7 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
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?
ECCA (échelle d'évaluation clinique des cicatrices d'acné) Grading (time frame: 3 months after the final treatment, Optional 6 months after final treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 7 Mar 2025.