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The MIRIA Acne Scar Study (MIRIA)

Primary Purpose

Acne Scars - Mixed Atrophic and Hypertrophic

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
MIRIA Laser
Sponsored by
AVAVA, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring Laser Treatment, Acne Scars, MIRIA Laser, Laser, AVAVA, All Skin Types, Scars

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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
  • 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.

Sites / Locations

  • AVAVA, Inc.Recruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Treatment with the MIRIA Laser

Arm Description

3-4 experimental treatments at 4-6 week intervals

Outcomes

Primary Outcome Measures

Improvement of Facial Acne Scars
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score, Physician Global Aesthetic Improvement Scale (PGAIS) Score, Subject Global Aesthetic Improvement Scale (SGAIS) Score, 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. ECCA Global Score Limits: Lowest Score (0) Much Improved, Highest Score (540) No Improvement PGAIS Score Limits: Much Improved (5), Much Worse (1) SGAIS Score Limits: Very Satisfied (6), Very Dissatisfied (1)

Secondary Outcome Measures

Full Information

First Posted
October 24, 2022
Last Updated
October 31, 2022
Sponsor
AVAVA, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT05597267
Brief Title
The MIRIA Acne Scar Study
Acronym
MIRIA
Official Title
The MIRIA Acne Scar Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Recruiting
Study Start Date
November 1, 2022 (Anticipated)
Primary Completion Date
September 1, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AVAVA, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Device Product Not Approved or Cleared by U.S. FDA
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

Brief 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. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic
Keywords
Laser Treatment, Acne Scars, MIRIA Laser, Laser, AVAVA, All Skin Types, Scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
75 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Treatment with the MIRIA Laser
Arm Type
Experimental
Arm Description
3-4 experimental treatments at 4-6 week intervals
Intervention Type
Device
Intervention Name(s)
MIRIA Laser
Intervention Description
4-6 experimental treatments at 4-6 weeks intervals
Primary Outcome Measure Information:
Title
Improvement of Facial Acne Scars
Description
A 1 point or greater reduction in facial acne scars severity using the Echelle d'Evaluation Clinique des Cicatrices d'Acne (ECCA) Score, Physician Global Aesthetic Improvement Scale (PGAIS) Score, Subject Global Aesthetic Improvement Scale (SGAIS) Score, 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. ECCA Global Score Limits: Lowest Score (0) Much Improved, Highest Score (540) No Improvement PGAIS Score Limits: Much Improved (5), Much Worse (1) SGAIS Score Limits: Very Satisfied (6), Very Dissatisfied (1)
Time Frame
3 months after the final treatment, Optional 6 months after final treatment

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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. Exclusion Criteria: 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 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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jhony Escobar, BS
Phone
857-702-0768
Email
jescobar@avavamedical.com
First Name & Middle Initial & Last Name or Official Title & Degree
Jemimah Desir, BS
Email
jdesir@avavamedical.com
Facility Information:
Facility Name
AVAVA, Inc.
City
Waltham
State/Province
Massachusetts
ZIP/Postal Code
02451
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jhony Escobar, BS
Phone
857-702-0768
Email
jescobar@avavamedical.com
First Name & Middle Initial & Last Name & Degree
Jemimah Desir, BS
Email
jdesir@avavamedical.com

12. IPD Sharing Statement

Learn more about this trial

The MIRIA Acne Scar Study

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