An interventional study of HCC_45 in Acne Scars - Mixed Atrophic and Hypertrophic, Ice Pick Scars and Rolling Scars, sponsored by IBSA Farmaceutici Italia Srl. Completed at 1 site in Italy. Open to participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2024-04-19.
Sponsored by IBSA Farmaceutici Italia Srl · Not applicable, Interventional, and Treatment
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.
307 studies on the registry are indexed under Cicatrix; 50 are open to participants now.
This study's enrollment of 30 is below the median of 39 across 251 interventional studies indexed under Cicatrix.
Browse Cicatrix studies →IBSA Farmaceutici Italia Srl is the lead sponsor of 11 studies on the registry; 5 are open to participants now.
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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).
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.
Device: HCC_45
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.
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)
Time frame: 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.
Time frame: Day 0, Day 30, Day 120
Efficacy questionnaire
Self assessment questionnaire regarding the efficacy of the study treatment on acne scars (score: very marked; marked; medium; light; absent;)
Time frame: Day 120
Treatment tolerance questionnaire
Self-assessment score: bad; poor; good; excellent
Time frame: Day 120
This study is completed, as verified in Jan 2023. You cannot join it, but the record below documents what was studied.
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IBSA Farmaceutici Italia Srl