Completed
Aesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen
What is being tested
Profhilo®
Device
Who is being recruted
From 40 to 65 Years
+37 Eligibility Criteria
How is the trial designed
Treatment Study
Interventional
Study Start: September 2018
Summary
Principal SponsorDerming SRL
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Study start date: September 11, 2018
Actual date on which the first participant was enrolled.The objective of this study was to investigate the aesthetic performance of the Hyaluronic acid (HA)-based dermal filler Profhilo® injected by a novel bio aesthetic point technique ("BAP" technique) in woman aged 40-65 years with mild-moderate skin flaccidity and roughness of the abdomen and inner arms.
Official TitleAesthetic Performance and Tolerance Evaluation of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Inner Arm and Abdomen
Principal SponsorDerming SRL
Last updated: January 27, 2026
Sourced from a government-validated database.Claim as a partner
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.Design Details
24 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Criteria
Female
Biological sex of participants that are eligible to enroll.From 40 to 65 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Criteria
8 inclusion criteria required to participate
age 40-65 years;
female sex;
3-4 abdomen and inner arm roughness/laxity grade according to a clinical reference scale;
asking for abdomen and inner arms laxity and roughness restoration;
Show More Criteria
29 exclusion criteria prevent from participating
Pregnancy;
lactation;
smokers;
alcohol or drug abusers;
Show More Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.Treatment Groups
Study Objectives
One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalThe 1st treatment was performed during the basal visit and repeated after 1 month.
3 mL of Profhilo® for each brachial zone, 1.5 mL for hemiabdomen 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 horizontal-levels for each tested areas (3-4-3 injection points respectively for the 1st, the 2nd and the 3rd horizontal-level). The amount of product to be injected was of 0.3 ml for each point.
Study Objectives
Primary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location
Suspended
CompletedOne Study Center