CompletedNot Applicable

Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

Italy40 participantsStarted 2020-09-25

Plain-language summary

The scope of this open label clinical trial is to evaluate and confirm the performance of Papix acne scar in the prevention and improvement of acne scars in subject suffering for mild to moderate acne. The product will be applied for 8 consecutive weeks and 3 clinical follow up visits will be performed.

Who can participate

Age range

12 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

. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
. Male or female subjects aged ≥ 12 years of any race;
. Subjects with any Fitzpatrick skin phototype;
. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
. Presence of acne scars (all types included), of grade mild or moderate according to SGA;
. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.

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

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks

Timeframe: four weeks of treatment

Trial details

NCT IDNCT04806594

SponsorRelife S.r.l.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2021-07-01

Results submitted2022-06-28

View on ClinicalTrials.gov More Acne trials

Plain-language summary

Who can participate

Age range

12 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

. Subject's or parents or guardian (depending on the age of the subject) written informed consent obtained prior to any study-related procedures;
. Male or female subjects aged ≥ 12 years of any race;
. Subjects with any Fitzpatrick skin phototype;
. Subjects with clinical diagnosis of mild to moderate acne vulgaris (IGA score 2 or 3) on the face;
. Presence of acne scars (all types included), of grade mild or moderate according to SGA;
. Subjects with cooperative attitude, able to comprehend the full nature and the purpose of the investigation, including possible risks and side effects, and able to comply with the requirements of the entire investigation (including ability to attend the planned visits according to the time limits), based on Investigator's judgement.

Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar.

Plain-language summary

Who can participate

Inclusion criteria

Questions worth asking your doctor

Questions for the trial coordinator

What they're measuring

Trial details

Exclusion criteria