AcneNCT04806594

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

A study testing Papix acne scar in people with Acne and Scars, run by Relife S.r.l. at 1 site in Italy.

Completed

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

Trial 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. Read more about this study

Who is it for?: Ages 12 years and older
Conditions the study is for: Acne, Scars
What is being tested?: Papix acne scar
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 40 participants
Where: 1 siteItaly
Study dates: 25 Sep 2020to 1 Jul 2021
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 12 years and older
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

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.

Who cannot join

Pregnant women
Severe acne at inclusion or any acne requiring systemic treatment;
Presence of facial warts or fungal infections;
Active dermatitis on the face, rosacea, active herpes simplex;
Keloids presence in the area to be treated or keloids development during the treatment period;
History of radiation or skin tumors in the/close to the area to be treated in the past 5 years;

Show all 18Show fewer

Laser ablative procedures within the last month;
Chemical peels within the last 6 months;
Use of topical treatments like antibiotics, corticosteroids, benzoyl peroxide, azelaic acid, hydroxy acids and other antinflammatory drugs within 2 weeks;
Use of topical retinoids within 4 weeks;
Use of systemic corticosteroids or antibiotics in the previous 30 days;
Use of systemic spironolactone/drospirenone or immunomodulators in the previous 3 months;
Use of oral retinoids or cyproterone acetate/chlormadinone acetate in the previous 6 months;
Use of scrub, alpha hydroxy acid (AHA), skin irritant products in the 2 days before study treatment start;
Subjects with any other clinically significant or unstable concurrent disease or skin condition or general condition that, in the Investigator's opinion, might interfere with the study evaluations;
Allergy, sensitivity or intolerance to the components of the investigational device formulations ingredients;
Concomitant or previous participation in other interventional clinical study in the past 3 months;
Subjects planning sun exposure or tanning booths or UV sources throughout the course of the study. In case of sun exposure this shall be limited and a protection cream (SPF 50+) shall be applied.

Trial locations and contacts

1 site in 1 country.

Italy1 site

Ospedale San Martino
Genova, 16132

Other trials in Italy

About this study

Official title: Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne

Read the detailed description

The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.

Conditions: Acne, Scars
Being tested: Papix acne scar
Keywords: cream, mild moderate acne, Papix, Papix acne scar, acne treatment
Medical subject headings: Acne Vulgaris, Cicatrix

What participants receive

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

Papix acne scarDevice
PapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration

Study groups in NCT04806594
Study group	Role	What they receive
Papix acne scar	Experimental	Papix acne scar gel for 8 consecutive weeks, 2 times per day Receives: Device: Papix acne scar

What is being measured

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

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks
The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.
Measured: four weeks of treatment

Secondary outcomes (8)

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Indicate the proportion of subjects with improved acne scars and marks with respect to baseline and, at the same time, without any new facial acne scars after 2 and 8 weeks of treatment. The improvement of acne scars and marks will be assessed as the change in the qualitative Scar Global Assessment (SGA) questionnaire
Measured: two weeks of treatment and 8 weeks of treatment, week 8 reported
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Proportion of subjects at week 2, 4 and 8 of treatment, without any new facial acne lesions with respect to baseline (Visit 1).
Measured: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Acne Investigator Global Assessment (IGA) Scores
To evaluate acne severity after 2 weeks (visit 2), 4weeks (visit 3) and 8 weeks (visit 4) of treatment, through the Investigator Global Assessment.
Acne Investigator Global Assessment (IGA). Five different grades were used to define the acne severity: 0 Clear, 1 Almost Clear, 2 Mild, 3 Moderate, 4 Severe;
Measured: assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)
Change of Skin Roughness
To evaluate the improvement of the skin roughness after 2, 4 and 8 weeks of treatment.through the Investigator Global Assessment Acne Investigator Global Assessment (IGA)
Measured: assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)
Number of Partecipants With Skin Texture Improvement
To evaluate the change in skin texture after 2, 4 and 8 weeks of treatment, through the Investigator Global Assessment. Acne Investigator Global Assessment (IGA).
Measured: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Number of Partecipants Compliant to Treatment
To evaluate the subject's adherence to treatment by the product accountability.
Measured: 8 weeks
Subject and Investigator Global Evaluation of Performance
To evaluate the subject's and Investigator's global evaluation of satisfaction with regards to the performance of PAPIX ACNE SCAR through a specific questionnaire.
Measured: 8 weeks of treatment ( visit 4)
Treatment Acceptability
To evaluate the subject's overall acceptability of the treatment through a specific questionnaire.
Measured: 8 weeks of treatment ( visit 4)

Timeline

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

25 Sep 20201 Jul 2021

First posted19 Mar 2021
Study start25 Sep 2020
Primary completion1 Jul 2021
Study completion1 Jul 2021

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for AcneStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.
Masking: None (open label)
Enrolment: 40 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04806594
Sponsor's protocol ID: ReGl/19/PAS-Acn/001
Status last verified: Nov 2024
First submitted: 13 Nov 2020
Last updated: 8 Jan 2025
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 8 Jan 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Open Label, Uncontrolled Clinical Investigation on the Safety and Clinical Performance of Papix Acne Scar in the Prevention and Improvement of Scars and Lesions Associated With Acne
ClinicalTrials.gov ID: NCT04806594
Acronym / sponsor ID: ReGl/19/PAS-Acn/001
Conditions: Acne, Scars
Keywords: cream, mild moderate acne, Papix, Papix acne scar, acne treatment
Study type: Interventional
Recruitment status: Completed
Enrolment: 40 participants (actual)
Lead sponsor: Relife S.r.l.Industry (pharma, biotech, devices)
Study start: 25 Sep 2020 (actual)
Primary completion: 1 Jul 2021 (actual)
Study completion: 1 Jul 2021 (actual)
First posted: 19 Mar 2021 (actual)
Results: Posted 8 Jan 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

The dermatologist will perform 3 clinical follow up visits to assess the efficacy and safety of the product.

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
Model description: Multicenter, open label, uncontrolled, single arm, post-market clinical follow-up study.

Arm	Type	Receives
Papix acne scar	Experimental	Device: Papix acne scarPapix acne scar gel for 8 consecutive weeks, 2 times per day

Who may qualify

Ages: 12 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (6 listed)

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;

Key exclusion criteria (18 listed)

Pregnant women
Severe acne at inclusion or any acne requiring systemic treatment;
Presence of facial warts or fungal infections;
Active dermatitis on the face, rosacea, active herpes simplex;
Keloids presence in the area to be treated or keloids development during the treatment period;

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Papix acne scarPapiX acne scar, class IIa medical device, gel for acne scar. to be applied 2 times per day during the 8 weeks of study duration	Device	Papix acne scar

Primary outcome

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks
Time frame: four weeks of treatment
The primary endpoint will be the proportion of subjects with acne scars and marks improved with respect to baseline and, at the same time, without any new facial acne scars after 4 weeks of treatment (treatment success). The improvement of acne scars and marks will be assessed as the change of at least one grade in the qualitative Scar Global Assessment (SGA) by Goodman and Baron between baseline and Week 4. The number of new acne scars will be assessed by count and comparison with baseline.

8 secondary outcomes

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Time frame: two weeks of treatment and 8 weeks of treatment, week 8 reported
Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After Treatment
Time frame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Acne Investigator Global Assessment (IGA) Scores
Time frame: assested at two weeks (visit 2), 4 weeks (visit 3) and 8 weeks (visit 4)
Change of Skin Roughness
Time frame: assested at two weeks, 4 weeks (visit 3) and 8 weeks (visit 4)
Number of Partecipants With Skin Texture Improvement
Time frame: assested at two weeks, 4 weeks and 8 weeks, week 8 reported
Number of Partecipants Compliant to Treatment
Time frame: 8 weeks
Subject and Investigator Global Evaluation of Performance
Time frame: 8 weeks of treatment ( visit 4)
Treatment Acceptability
Time frame: 8 weeks of treatment ( visit 4)

Results and safety

Results posted to the registry on 8 Jan 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.	40	37

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

Time frame: four weeks of treatment. Number. Unit: participants

Measure	No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype n = 39
Value	5

Population analysed: PPAS population: Per-Protocol analysis set (PPAS): all patients of the FAS who also meet all inclusion/exclusion criteria and who do not have any major protocol deviation (i.e. wrong inclusion, use of forbidden concomitant medications, etc.).

8 secondary outcomes are reported in the full results.

Adverse events

Time frame: All subjects enrolled were treated with PAPIX ACNE SCARS for 8 weeks. Other adverse events reported at 2.6% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Safety Population)	0 of 40 (0%)	1 of 40 (2.5%)	0 of 40

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 8 Jan 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Aurora Parodi principal investigator

Ospedale Policlinico San Martino

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Papix acne scar in people with Acne and Scars, run by Relife S.r.l. 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 6 inclusion and 18 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 8 Jan 2025. 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?

Yes. Results are posted in the registry (first posted 8 Jan 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Number of Partecipants With Improvement of Acne Scars and Marks and Without New Acne Scars After 4 Weeks (time frame: four weeks of treatment). 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 NCT04806594.

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 8 Jan 2025.