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| Name | Class |
|---|---|
| Derming SRL | OTHER |
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Acne scars represent a frequent complication of moderate/severe acne and may negatively impact on psychosocial and physical well-being of acne patients. Several types of acne scars have been classified and the same patient is likely to have more than one type. Each type can be treated with varying degrees of success. The main acne scars are the following:
Atrophic or Depressed Scarring:
Open label clinical trial, conducted by 1 center under dermatological control.
Primary aim of the study is to evaluate the efficacy and the safety of the deep injection of HCC_45 in acne scars of the face (ice picks, rolling, boxcars).
Secondary endpoint is self-assessment questionnaire regarding treatment efficacy and tolerance.
HCC_45 is a resorbable medical device 2 ml nonpyrogenic pre-filled syringe, containing 2 ml of hyaluronic acid for intradermal use. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HCC_45 treatment group | Experimental | Treatment of acne scars of the face by using a subcision+injection technique: the needle (25 G) or cannula (25 G) (wider areas are treated with the cannula) is inserted into the skin and made to move with a back-and-forth motion in order to detach scar collagen bundles. Then 1 syringe (2 ml) of HCC_45 is injected. Day 0: Information and consent form provided, Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. First treatment of HCC_45 (refer to study protocol). Day 30 (1 month after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. Second treatment of HCC_45 (refer to study protocol). Day 120 (4 months after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. NO treatment, Self-evaluation questionnaire. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| HCC_45 | Device | Dosage form: HCC_45 is a resorbable medical device 2 ml non-pyrogenic pre-filled syringe, containing 2 ml of hyaluronic acid for intradermal use. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation. |
| Measure | Description | Time Frame |
|---|---|---|
| Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection | Visual score from 1 (milder scarring) to 4 (severe scarring) (Goodman and Baron Grading Scale of Postacne Scarring) | Day 0, Day 30, Day 120 |
| Change from Baseline of Skin's surface Profilometry at 30 days and at 120 days post-injection | A measurement of the skin surface affected by acne scars is taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters in vivo or on skin replicas, the software compares directly the different images obtained at the times foresee by the protocol. | Day 0, Day 30, Day 120 |
| Measure | Description | Time Frame |
|---|---|---|
| Efficacy questionnaire | Self assessment questionnaire regarding the efficacy of the study treatment on acne scars (score: very marked; marked; medium; light; absent;) | Day 120 |
| Treatment tolerance questionnaire |
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Inclusion Criteria:
Exclusion Criteria:
The use of other drugs, not mentioned above, can be authorized by the Investigator. The trade name, the dosage, the start and stop date of the therapy will be reported on Case Record Form (CRF).
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| Name | Affiliation | Role |
|---|---|---|
| Adele Sparavigna, MD | DERMING S.r.l., Clinical Research and Bioengineering Institute | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| DERMING S.r.l., Clinical Research and Bioengineering Institute | Milan | Lombardy | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39365190 | Derived | Sparavigna A, Grimolizzi F, Cigni C, Lualdi R, Bellia G. Dual-Plane Treatment With Highly Concentrated Hybrid Cooperative Complexes of Hyaluronans for Facial Atrophic Acne Scars. Dermatol Surg. 2025 Feb 1;51(2):152-156. doi: 10.1097/DSS.0000000000004387. Epub 2024 Oct 4. |
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| ID | Term |
|---|---|
| D006984 | Hypertrophy |
| ID | Term |
|---|---|
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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30 subjects undergoing HCC_45 treatment of acne scars of the face by using a subcision + injection technique, the Needle (25 Gauge) or Cannula (25 Gauge) (wider areas are treated with Cannula) is inserted into the skin and made to move with a back-and-forth motion in order to detach scar collagen bundles. Then HCC_45 is injected. 3 visits: Day 0 (treatment) Day 30 (1 month after Day 0 treatment) Day 120 (4 months after Day 0 - follow-up).
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Self-assessment score: bad; poor; good; excellent
| Day 120 |