Evaluation of Efficacy and Safety of HCC_45 for the Correction of Acne Scars of the Face

NCT05691049 | Completed

• 1 other identifier: E0222
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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:

• Ice pick: An ice pick scar has a wide shaft that narrows down to the tip. It resembles a hole that's wide at the top and narrows to a point as it goes deeper into the skin. Such an indentation is common and one of the most challenging scars to heal. This scar is more frequent on forehead and upper cheeks, where skin is thinner.
• Rolling: These scars are typically found on the lower cheeks and jaw, where skin is thicker. The indents have sloping edges that makes the skin look uneven and wavy.
• Boxcar: Boxcar scars are indents that have sharper edges. Those edges go down deep into the skin. These scars are common on the lower checks and jaw.

Conditions

Acne Scars - Mixed Atrophic and Hypertrophic; Ice Pick Scars; Rolling Scars; Boxcar Scars

Keywords

Acne scars; Hyaluronic acid; Ice pick Scars; Rolling scars; Boxcar scars

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (2)

• Efficacy questionnaire

  Day 120

• Treatment tolerance questionnaire

  Day 120

Study Arms (1)

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.

Device: HCC_45

Interventions

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.

HCC_45 treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• caucasian subjects of both sexes;
• age \>18years
• asking for acne scars treatment;
• presenting acne scars (ice picks, rollings, boxcars);
• available and able to return to the study site for the post-procedural follow-up examinations;
• agreeing to present at each study visit without make-up;
• accepting to not change their habits regarding food, physical activity, make-up use, face cosmetic and cleansing products;
• accepting not to expose their face to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;
• accepting to sign the Informed consent form.

You may not qualify if:

• Dependent on the volunteers' characteristics:
• smokers;
• performing in the 6 month before the trial beginning HA injections, radiofrequency treatment, toxin treatment;
• contraindication or know allergy to the devices' components or to the treatment;
• participation in a similar study actually or during the previous 3 months
• known pregnancy
• occurrence of pregnancy during the study
• Dependent on a clinical condition: Dermatological disease:
• Dermatitis;
• presence of cutaneous disease on the tested area,different from those under study
• recurrent facial/labial herpes;
• clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, severe rosacea, scleroderma, local infections and severe acne).
• Dependent on a clinical condition: General disease:
• Diabetes, coagulation disorders, connective tissue disorders, lipodystrophy or other systemic disease;
• HIV and/or immunosuppressive disease;

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Derming SRL: collaborator

Study Sites (1)

DERMING S.r.l., Clinical Research and Bioengineering Institute

Milan, Lombardy, Italy

Location

Related Publications (1)

• 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.

  PMID: 39365190 DERIVED

MeSH Terms

Conditions

Hypertrophy

Condition Hierarchy (Ancestors)

Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Study Officials

• Adele Sparavigna, MD

  DERMING S.r.l., Clinical Research and Bioengineering Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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).

Study Record Dates

• First Submitted: December 20, 2022
• First Posted: January 19, 2023
• Study Start: November 24, 2022
• Primary Completion: September 30, 2023
• Study Completion: September 30, 2023
• Last Updated: April 19, 2024

Record last verified: 2023-01

Locations

IT (1)