Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands

NCT05590364 | Completed

• 1 other identifier: E0122
• Study Type: interventional
• Target: 51
• Locations: 1 country
• Sites: 1

Brief Summary

People lose collagen all over the body, not just in the face; skin roughness and laxity of the dorsum of the hands can result from chrono and photo-aging. This skin roughness and laxity can range from very mild to severe; injection procedures can provide new tone and firmness to the skin of the hand dorsum. Dermal fillers are the most used non-permanent injectable materials available today to correct skin flaccidity and roughness on the dorsum of the hands. They give immediate aesthetic effect due to elastic gel matrix injected and impart longer term effects due to bio stimulation, promoting new collagen formation. The objective of this study is to investigate the aesthetic performance of the Hyaluronic acid (HA)- based dermal filler Profhilo® Body injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage, 1,5 ml for each hand. Volunteers of both sexes, aged 18-65 years with mild-moderate skin roughness and laxity at the level of hand dorsum are to be treated.

Conditions

Skin Laxity; Skin Roughness

Keywords

Skin laxity; Skin roughness; Profhilo Body; Hyaluronic Acid; Hybrid Cooperative Complexes

Outcome Measures

Primary Outcomes (5)

• Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection

  Visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity)

  Day 0, Day 30, Day 120

• Change from Baseline of Skin density (profilometry) at 30 days and at 120 days post-injection

  A picture of the skin is taken thanks to Primos compact portable device (GFMesstechnik) and a 3D representation is elaborated by Primos software.

  Day 0, Day 30, Day 120

• Change from Baseline of Superficial and deep skin plastoelasticity at 30 days and at 120 days post-injection

  Measurement of the principal torsiometric parameters Ue (immediate extensibility), Uf (final extensibility), Uv (viscoelasticity) and Ur (immediate elastic recovery) by the instrument Dermal Torque Meter (Dia-Stron Ltd., UK)

  Day 0, Day 30, Day 120

• Change from Baseline of Tissue dielectric constant value of superficial and deep skin layers at 30 days and at 120 days post-injection

  Non-invasive measurements of dielectric constant of the skin and subcutaneous fat by MoistureMeterD (Delfin Technologies, Kuopio - Finland). MoistureMeterD measures the changes in the total water content in the tissue with 0.5mm and 1.5mm probes.

  Day 0, Day 30, Day 120

• Change from Baseline of Photographic evaluation at 30 days and at 120 days post-injection

  2D pictures of the dorsum of both hands are taken in order to support the aesthetic result assessment

  Day 0, Day 30, Day 120

Secondary Outcomes (2)

• Efficacy questionnaire

  Day 30, Day 120

• Treatment tolerance questionnaire

  Day 30, Day 120

Study Arms (1)

Profhilo® Body treatment group

EXPERIMENTAL

1.5 ml per hand injected by a blunt tip microcannula (25G or 22G, preferably 22G), with fanning technique through a single entry point performing 5 passages and injecting 0,3 ml per passage. Day 0: Information and consent form provided. Clinical photography, Clinical assessment, Instrumental assessment, First treatment of Profhilo® (refer to study protocol). Day 30 (1 month after day 0): Clinical photography, Clinical assessment, Instrumental assessment, Second treatment of Profhilo® (refer to study protocol), Self-evaluation questionnaire. Day 120 (4 months after day 0): Clinical photography, Clinical assessment, Instrumental assessment, NO treatment, Self-evaluation questionnaire.

Device: Profhilo® Body

Interventions

Profhilo® Body DEVICE

Dosage form: Profhilo® Body (IBSA Farmaceutici Italia S.r.l.) is a resorbable medical device 3.25 ml non-pyrogenic pre-filled syringe, containing 3 ml of 3.2% hyaluronic acid for intradermal use (48 mg H-HA + 48 mg L-HA) dissolved in 3 ml of saline buffered sodium chloride.

Profhilo® Body treatment group

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• female and male sex, not necessarily 1:1 ratio;
• age 18-65 years;
• asking for hands 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 hands;
• accepting not to expose their hands to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study, without appropriate sun protection;

You may not qualify if:

• Pregnancy;
• lactation;
• smokers;
• alcohol or drug abusers;
• subjects not in menopause who do not use adequate contraceptive precautions in order to avoid pregnancies during the study;
• Body Mass Index (BMI) variation (± 1) during the study period;
• performing non-surgical skin aesthetic procedures for hands in the 6 months prior to the study start;
• aesthetic surgical procedure for the hands in the past;
• change in the normal habits regarding food, physical activity, cosmetic products and cleansing for the hands 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 6 months.)
• presence of cutaneous disease on the tested area, as lesions, scars, malformations;
• clinical and significant skin condition on the test area (e.g. active eczema, psoriasis, sclerodermia, local infections).
• Diabetes;

Sponsors & Collaborators

• IBSA Farmaceutici Italia Srl: lead
• Derming SRL: collaborator

Study Sites (1)

DERMING S.r.l., Clinical Research and Bioengineering Institute

Milan, Lombardy, Italy

Location

MeSH Terms

Conditions

Cutis Laxa

Condition Hierarchy (Ancestors)

Skin Diseases, Genetic; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Study Officials

• Adele Sparavigna, MD

  DERMING S.r.l., Clinical Research and Bioengineering Institute

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Masking Details: No masking
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 55 subjects undergoing Profhilo Body treatment in the back of the hands, 3 visits: Day 0 (treatment) Day 30 (1 month after Day 0 treatment) Day 120 (4 months after Day 0 - follow-up).

Study Record Dates

• First Submitted: September 27, 2022
• First Posted: October 21, 2022
• Study Start: November 7, 2022
• Primary Completion: June 8, 2023
• Study Completion: June 8, 2023
• Last Updated: September 28, 2023

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)