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Aesthetic Performance of "Profhilo®" Injective Intradermal Treatment for the Neck

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04002856
Recruitment Status : Completed
First Posted : July 1, 2019
Last Update Posted : July 18, 2019
Sponsor:
Information provided by (Responsible Party):
Derming SRL

Brief Summary:
The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" techinique ) in woman aged 40-65 years with skin flaccidity and roughness of the neck.

Condition or disease Intervention/treatment Phase
Skin Manifestations Device: Profhilo® Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Aesthetic Performance and Tolerance Evaluation of "Profhilo®" Injective Intradermal Treatment for the Skin Roughness and Laxity of the Neck
Actual Study Start Date : February 18, 2019
Actual Primary Completion Date : June 21, 2019
Actual Study Completion Date : June 21, 2019

Arm Intervention/treatment
Experimental: Profhilo®

The 1st treatment was performed during T0 visit, after the basal evaluations planned by the study procedure and repeated after 1 month (T1).

2 mL of Profhilo® was injected into the middle-deep dermis by needle (29 G) using a bolus technique called "BAP" (Bio Aesthetic Point technique); this technique involves a series of 10 micro-wheals on 3 vertical-lines (3-4-3 ). The amount of product injected was 0.2 ml for each injection point.

Device: Profhilo®
Profhilo® (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 2.25 ml non-pyrogenic pre-filled syringe, containing 2 ml of 3.2% hyaluronic acid for intradermal use (32 mg H-HA + 32 mg L-HA dissolved in 2 ml of saline buffered sodium chloride




Primary Outcome Measures :
  1. Change from baseline of neck skin roughness and laxity clinical grade [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    Skin roughness and laxity clinical grade, according to a visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity).

  2. Change from baseline of superficial skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    Skin electrical capacitance value was measured mono-laterally on the neck with Corneometer CM825 (Courage - Khazaka, Köln, Germany). The measure of the skin capacitance properties is an indirect expression of its hydration level.

  3. Change from baseline of deep skin hydration [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    Tissue dielectric constant value of superficial and deep skin layers was measured mono-laterally on the neck with MoistureMeterD (Delfin Technologies, Kuopio - Finland)

  4. Change from baseline of skin density [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    A little skin area of about 7 cm2 at level of neck was pinched, in standardized conditions, using a specific device. Because of this "pinch" the skin profile changes depending on cutaneous density; when the skin is slack the "pinch" forms a lot of wrinkles. A picture of the skin pinched was taken thanks to Primos compact portable device (GFMesstechnik); Primos software is able to measure skin principal profilometric parameters.

  5. Change from baseline of skin plastoelasticity [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    Superficial and deep skin plastoelasticity was measured mono-laterally on the neck with the instrument Dermal Torque Meter (Dia-Stron Ltd., UK).

  6. Change from baseline of photographic documentation [ Time Frame: Baseline (T0), 1 month (T1), 4 months (T2) ]
    2D pictures of the neck



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • female sex,
  • 40-65 years,
  • 3-4 neck roughness/laxity grade according to a clinical reference scale;
  • asking for neck laxity and roughness restoration;
  • available and able to return to the study site for the post-procedural follow-up examinations;
  • accepting to not change their habits regarding food, physical activity, cosmetic and cleansing products for the neck;
  • accepting to not expose their neck 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:

  • Pregnancy;
  • lactation;
  • smokers;
  • alcohol abuse and/or drug use;
  • subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
  • subjects not in menopause who do not accept to perform the pregnancy test at T0 (before the 1st aesthetic procedure) and at T1 (1 month after the 1st injection treatment execution, before the 2nd aesthetic procedure);
  • Body Mass Index (BMI) variation (± 1) during the study period;
  • performing skin treatments for neck aesthetic correction (biomaterials implants, neck lifting, botox injections, laser, chemical peeling) in the 6 months prior to the study start;
  • performing permanent filler in the past;
  • change in the normal habits regarding food, physical activity, neck cosmetic and cleansing use during the month preceding the test;
  • sensitivity to the test product or its ingredients (to be assessed by the investigator during the baseline visit);
  • subjects whose insufficient adhesion to the study protocol is foreseeable;
  • participation in a similar study currently or during the previous 9 months;
  • dermatitis;
  • presence of cutaneous disease on the tested area, as lesions, scars, malformations;
  • 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);
  • diabetes;
  • endocrine disease;
  • hepatic disorder;
  • renal disorder;
  • cardiac disorder;
  • pulmonary disease;
  • cancer;
  • neurological or psychological disease;
  • inflammatory/immunosuppressive disease;
  • drug allergy;
  • Anticoagulants and antiplatelet drugs, anti-histaminic, topic and systemic corticosteroids, narcotic, antidepressant, immunosuppressive drugs (with the except of contraceptive or hormonal treatment starting more than 1 year ago);
  • using of drugs able to influence the test results in the investigator opinion.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04002856


Locations
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Italy
DERMING
Milano, MI, Italy, 20159
Sponsors and Collaborators
Derming SRL
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Responsible Party: Derming SRL
ClinicalTrials.gov Identifier: NCT04002856    
Other Study ID Numbers: E0319
First Posted: July 1, 2019    Key Record Dates
Last Update Posted: July 18, 2019
Last Verified: June 2019

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Skin Manifestations