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Evaluation of Efficacy and Safety of Profhilo® Structura for the Correction of Acne Scars of the Face

Primary Purpose

Acne Scars - Mixed Atrophic and Hypertrophic, Ice Pick Scars, Rolling Scars

Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Profhilo® Structura
Sponsored by
IBSA Farmaceutici Italia Srl
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acne Scars - Mixed Atrophic and Hypertrophic focused on measuring Acne scars, Hyaluronic acid, Hybrid Cooperative Complexes, Profhilo Structura, Ice pick Scars, Rolling scars, Boxcar scars

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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 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).

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Profhilo® Structura treatment group

Arm Description

Treatment 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 Profhilo® Structura is injected. Day 0: Information and consent form provided, Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. First treatment of Profhilo® Structura (refer to study protocol). Day 30 (1 month after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. Second treatment of Profhilo® Structura (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.

Outcomes

Primary Outcome Measures

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)
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.

Secondary Outcome Measures

Efficacy questionnaire
Self assessment questionnaire regarding the efficacy of the study treatment on acne scars (score: very marked; marked; medium; light; absent;)
Treatment tolerance questionnaire
Self-assessment score: bad; poor; good; excellent

Full Information

First Posted
December 20, 2022
Last Updated
January 18, 2023
Sponsor
IBSA Farmaceutici Italia Srl
Collaborators
Derming SRL
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1. Study Identification

Unique Protocol Identification Number
NCT05691049
Brief Title
Evaluation of Efficacy and Safety of Profhilo® Structura for the Correction of Acne Scars of the Face
Official Title
Interventional, Post-marketing, Local, Mono-centric Study for Evaluation of Efficacy and Safety of Profhilo® Structura for the Correction of Acne Scars of the Face
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
November 24, 2022 (Actual)
Primary Completion Date
July 2023 (Anticipated)
Study Completion Date
September 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
IBSA Farmaceutici Italia Srl
Collaborators
Derming SRL

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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 Profhilo Structura® in acne scars of the face (ice picks, rolling, boxcars). Secondary endpoint is self-assessment questionnaire regarding treatment efficacy and tolerance. ProfhiloStructura® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2 ml nonpyrogenic pre-filled syringe, containing 2 ml of 4,5% hyaluronic acid for intradermal use (45 mg HHA + 45 mg L-HA dissolved in 1,5 ml of saline buffered sodium chloride - IBSA Farmaceutici Italia S.r.l. - ITALY. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acne Scars - Mixed Atrophic and Hypertrophic, Ice Pick Scars, Rolling Scars, Boxcar Scars
Keywords
Acne scars, Hyaluronic acid, Hybrid Cooperative Complexes, Profhilo Structura, Ice pick Scars, Rolling scars, Boxcar scars

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
30 subjects undergoing Profhilo Structura 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 Profhilo Structura 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)
Allocation
N/A
Enrollment
30 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Profhilo® Structura treatment group
Arm Type
Experimental
Arm Description
Treatment 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 Profhilo® Structura is injected. Day 0: Information and consent form provided, Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. First treatment of Profhilo® Structura (refer to study protocol). Day 30 (1 month after day 0): Clinical assessment, Digital clinical pictures, Instrumental assessment, Profilometry measurement. Second treatment of Profhilo® Structura (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.
Intervention Type
Device
Intervention Name(s)
Profhilo® Structura
Intervention Description
Dosage form: Profhilo® Structura (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2 ml non-pyrogenic pre-filled syringe, containing 2 ml of 4.5% hyaluronic acid for intradermal use (45 mg H-HA + 45 mg L-HA) dissolved in 1.5 ml of saline buffered sodium chloride. The principal component of the medical device is Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
Primary Outcome Measure Information:
Title
Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection
Description
Visual score from 1 (milder scarring) to 4 (severe scarring) (Goodman and Baron Grading Scale of Postacne Scarring)
Time Frame
Day 0, Day 30, Day 120
Title
Change from Baseline of Skin's surface Profilometry at 30 days and at 120 days post-injection
Description
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.
Time Frame
Day 0, Day 30, Day 120
Secondary Outcome Measure Information:
Title
Efficacy questionnaire
Description
Self assessment questionnaire regarding the efficacy of the study treatment on acne scars (score: very marked; marked; medium; light; absent;)
Time Frame
Day 120
Title
Treatment tolerance questionnaire
Description
Self-assessment score: bad; poor; good; excellent
Time Frame
Day 120

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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 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).
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Adele Sparavigna, MD
Phone
0223183475
Email
direzione.derming@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Roberto Lualdi, MD
Phone
0223183475
Email
direzione.derming@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Adele Sparavigna, MD
Organizational Affiliation
DERMING S.r.l., Clinical Research and Bioengineering Institute
Official's Role
Principal Investigator
Facility Information:
Facility Name
DERMING S.r.l., Clinical Research and Bioengineering Institute
City
Milano
State/Province
Lombardia
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Adele Sparavigna
Phone
0223183475
Email
direzione.derming@gmail.com
First Name & Middle Initial & Last Name & Degree
Adele Sparavigna, MD

12. IPD Sharing Statement

Learn more about this trial

Evaluation of Efficacy and Safety of Profhilo® Structura for the Correction of Acne Scars of the Face

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