Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment with the MIRIA Laser | Experimental | 3-4 experimental treatments at 4-6 week intervals |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MIRIA Laser | Device | 4-6 experimental treatments at 4-6 weeks intervals |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | 3 months after the final treatment, Optional 6 months after final treatment |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | From enrollment up to3 months after the final treatment, Optional up to 6 months after final treatment |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Enchantress Dermatology | Miami | Florida | 33173 | United States | ||
| AVAVA, Inc. |
Data is not currently being planned for sharing.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Sep 25, 2025 |
| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| D002921 | Cicatrix |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D005355 | Fibrosis |
| D010335 | Pathologic Processes |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| 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 |
| 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) | Through study completion, an average of 12 months |
| Waltham |
| Massachusetts |
| 02451 |
| United States |
| Laser and Skin Surgery Center of New York | New York | New York | 10010 | United States |