CompletedNot Applicable

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

Italy30 participantsStarted 2022-11-24

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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. Exclusion Criteria: * 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 d…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection

Timeframe: Day 0, Day 30, Day 120

Change from Baseline of Skin's surface Profilometry at 30 days and at 120 days post-injection

Timeframe: Day 0, Day 30, Day 120

Trial details

NCT IDNCT05691049

SponsorIBSA Farmaceutici Italia Srl

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-09-30

View on ClinicalTrials.gov More Acne Scars - Mixed Atrophic and Hypertrophic trials