Clinical Investigation on the Safety and Clinical Perform... | NCT04806594

NCT04806594

Protocol Section

Identification Module

Results Section

Participant Flow Module

Annotation Section

No data available

No data is available for this block.

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module

Status Module

Sponsor/Collaborators Module

Oversight Module

Description Module

Conditions Module

Design Module

Interventional Study Design

Biospecimen

No data available

No data is available for this block.

Arms/Interventions Module

Label	Type	Description	Intervention Names
Papix acne scar	Experimental	Papix acne scar gel for 8 consecutive weeks, 2 times per day	Device: Papix acne scar

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Papix acne scar	Device	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	Papix acne scar

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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.	four weeks of treatment

Secondary Outcomes

Measure	Description	Time Frame
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

Measure	Description	Time Frame
Number of Partecipants With Adverse Events	To evaluate the local and general tolerability of PAPIX ACNE SCAR.	two weeks, 4 weeks and 8 weeks of treatment

Eligibility Module

Eligibility Criteria

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.

Exclusion Criteria:

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;
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.

Contacts/Locations Module

Name	Affiliation	Role
Aurora Parodi	Ospedale Policlinico San Martino	Principal Investigator

Facility	Status	City	State	ZIP	Country	Contacts
Ospedale San Martino		Genova		16132	Italy

References Module

No data available

No data is available for this block.

IPD Sharing Statement Module

A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).

Arm/Group Information

ID	Title	Description
FG000	PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.	Papix acne scar gel for 8 consecutive weeks, 2 times per day PAPIX ACNE SCAR was topically applied twice a day for 8 weeks, 2 FTU (finger-tip units) in the morning and in 2 FTU the evening before bedtime, on the face, and massaged gently into the skin until absorbed.

Periods

Title

Milestones

Reasons Not Completed

Overall Study

Type	Comment	Milestone Data
STARTED		FG00040 subjects
COMPLETED		FG00037 subjects
NOT COMPLETED		FG0003 subjects

Type	Comment	Reasons
Withdrawal by Subject		FG0002 subjects
Did never apply the study product and did not attend following visits.		FG0001 subjects

Baseline Characteristics Module

Arm/Group Information

ID	Title	Description
BG000	PAPIX ACNE SCAR, Topically Applied Twice a Day for 8 Weeks.	Patients will be instructed to use PAPIX ACNE SCAR applied twice a day, in the morning and in the evening before bedtime, and massaged gently into the skin until absorbed. PAPIX ACNE SCAR shall be applied only on the lesions, where possible. The treatment duration will be of 8 weeks

Units	Counts
Participants	BG000

Baseline Measures

Title	Description	Population Description	Parameter Type	Dispersion Type	Unit of Measure	Calculate Percentage	Denominator Units Selected	Denominators	Classes
Age, Categorical		A total of 40 subjects were enrolled in the study and 39 of them started the treatment, 9 male (23.1%) and 30 females (76.9%). The global range was between 12 and 65 years. Overall, three subjects interrupted prematurely the study (one of them never started the treatment and two withdrew during the study).

Outcome Measures Module

Outcome Measures

Type

Title

Description

Population Description

Reporting Status

Anticipated Posting Date

Parameter Type

Dispersion Type

Unit of Measure

Calculate Percentage

Time Frame

Units Analyzed

Denominator Units Selected

Arm/Group Information

Denominators

Classes

Analyses

Primary

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.

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.).

Posted

Number

participants

four weeks of treatment

ID	Title	Description
OG000	No. 39 Subjects, Male or Female, Aged ≥ 12 Years, of Any Race, With Any Fitzpatrick Skin Phototype

Adverse Events Module

Arm/Groups

ID	Title	Description	Deaths (Affected)	Deaths (At Risk)	Serious Events (Affected)	Serious Events (At Risk)	Other Events (Affected)	Other Events (At Risk)
EG000	Safety Population)	To evaluate the local and general tolerability of PAPIX ACNE SCAR. Adverse events and adverse reactions were recorded and evaluated.

Term	Organ System	Source Vocabulary	Assessment Type	Notes	Statistical Information
mild foot contusion).	General disorders		Systematic Assessment

More Info Module

Certain Agreements

Title	Organization	Phone	Extension	Email
Clinical Trial Coordinator	Relife Srl	055 56809345		sdipalma@relifecompany.it

Uploaded Document Information

Type	Includes Protocol	Includes SAP	Includes ICF	Document Label	Document Date	Document Uploaded Date	Document File Name
Prot	Yes	No	No	Study Protocol	Jul 2, 2020	Apr 17, 2024	Prot_000.pdf
SAP	No	Yes	No	Statistical Analysis Plan	Nov 9, 2021	Jun 20, 2022	SAP_001.pdf

Submission Tracking

No data available

No data is available for this block.

Condition Browse Module

ID	Term
D000152	Acne Vulgaris
D002921	Cicatrix

ID	Term
D017486	Acneiform Eruptions
D012871	Skin Diseases
D017437	Skin and Connective Tissue Diseases
D012625	Sebaceous Gland Diseases

Intervention Browse Module

No data available

No data is available for this block.

Masking Info

EG0001 events1 affected40 at risk