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Acne Scars - Mixed Atrophic and HypertrophicNCT05691049

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

A study testing HCC_45 in people with Acne Scars - Mixed Atrophic and Hypertrophic and Ice Pick Scars, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and olderHealthy volunteers can take part
What is being tested?
HCC_45
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteItaly
Study dates
24 Nov 2022to 30 Sep 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • Healthy volunteers accepted
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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
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  • 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;
  • cancerous or precancerous lesions in the either right or left midface;
  • severe allergies manifested by a history of anaphylaxis, or history or presence of severe multiple allergies;
  • alcohol or drug abusers;
  • Dependent on a pharmacological treatment:
  • Anti-inflammatory drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting more than 1 year ago);
  • assumption of drugs able to influence the test results in the investigator opinion.
  • 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).

Trial locations and contacts

1 site in 1 country.

Italy1 site

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

    Milan, Lombardy

Other trials in Italy

About this study

Official title: Interventional, Post-marketing, Local, Mono-centric Study for Evaluation of Efficacy and Safety of HCC_45 for the Correction of Acne Scars of the Face

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.
Read the detailed description

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.

Being tested
HCC_45
Keywords
Acne scars, Hyaluronic acid, Ice pick Scars, Rolling scars, Boxcar scars
Medical subject headings
Hypertrophy

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HCC_45Device

    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.

Study groups in NCT05691049
Study groupRoleWhat they receive
HCC_45 treatment groupExperimentalTreatment 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.
Receives: Device: HCC_45

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    Measured: Day 0, Day 30, Day 120

  2. 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.

    Measured: Day 0, Day 30, Day 120

Secondary outcomes (2)

  1. Efficacy questionnaire

    Self assessment questionnaire regarding the efficacy of the study treatment on acne scars (score: very marked; marked; medium; light; absent;)

    Measured: Day 120

  2. Treatment tolerance questionnaire

    Self-assessment score: bad; poor; good; excellent

    Measured: Day 120

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted19 Jan 2023
  2. Study start24 Nov 2022
  3. Primary completion30 Sep 2023
  4. Study completion30 Sep 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
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).
Masking
None (open label)
Enrolment
30 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05691049
Sponsor's protocol ID
E0222
Status last verified
Jan 2023
First submitted
20 Dec 2022
Last updated
19 Apr 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 39365190

Questions about this trial

What is this clinical trial studying?

A study testing HCC_45 in people with Acne Scars - Mixed Atrophic and Hypertrophic and Ice Pick Scars, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 9 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection (time frame: Day 0, Day 30, Day 120). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05691049, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Apr 2024.

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