The MIRIA Acne Scar Study

Acne Scars - Mixed Atrophic and Hypertrophic Clinical Trial

— MIRIA  

Official title:

The MIRIA Acne Scar Study

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05597267
• Other study ID #: AV-22-002
• Status: Recruiting
• Phase: N/A
• Start date: November 4, 2022
• Est. completion date: December 31, 2024

Study information

• Verified date: December 2023
• Source: AVAVA, Inc.
• Contact: Jhony Escobar, BS
• Phone: 857-702-0768
• Email: studies[@]avavaskin.com
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 75
• Est. completion date: December 31, 2024
• Est. primary completion date: December 31, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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.

Related Conditions & MeSH terms

• Acne Scars - Mixed Atrophic and Hypertrophic
• Acne Vulgaris
• Cicatrix
• Hypertrophy

Intervention

Device:
• MIRIA Laser
4-6 experimental treatments at 4-6 weeks intervals

Locations

Country	Name	City	State
United States	Enchantress Dermatology	Miami	Florida
United States	Laser and Skin Surgery Center of New York	New York	New York
United States	AVAVA, Inc.	Waltham	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
AVAVA, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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)	3 months after the final treatment, Optional 6 months after final treatment