MIRIA Laser
Device4-6 experimental treatments at 4-6 weeks intervals
NCT Number: NCT05597267
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.
This study is active but is not currently recruiting participants.
18 year–65 year
All sexes
Interventional
Not applicable
Enchantress Dermatology, Miami, Florida, United States
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
4-6 experimental treatments at 4-6 weeks intervals
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)
Time frame: From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment
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.
Time frame: Up to 3 months after the final treatment, Optional up to 6 months after final treatment
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
Time frame: Through study completion, an average of 12 months
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)
AVAVA, Inc.
Industry
Acronym: MIRIA
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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