Skin LaxityNCT05590364
Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
A study testing Profhilo® Body in people with Skin Laxity and Skin Roughness, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Skin Laxity, Skin Roughness
- What is being tested?
- Profhilo® Body
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 1 siteItaly
- Study dates
- 7 Nov 2022to 8 Jun 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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;
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- 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;
- endocrine disease;
- hepatic disorder;
- renal disorder;
- cardiac disorder;
- pulmonary disease;
- cancer;
- neurological or psychological disease;
- inflammatory/immunosuppressive disease;
- drug allergy Exclusion criteria due to ongoing pharmacological treatment
- 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. 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 concomitant medication form.
Trial locations and contacts
1 site in 1 country.
Italy1 site
DERMING S.r.l., Clinical Research and Bioengineering Institute
Milan, Lombardy
About this study
Official title: Interventional, Post-marketing, Local, Mono-centric Study for Evaluation of Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
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.
Read the detailed description
Open, monocentric. 3 visits, 55 subjects.
Primary endpoint of the study is the evaluation of performance and tolerance of Profhilo Body (3ml) treatment in the back of the hands ( or dorsum of the hands). Secondary endpoint is self-assessment questionnaire by both doctors and volunteers.
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. - IBSA Farmaceutici Italia S.r.l. - ITALY. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
- Conditions
- Skin Laxity, Skin Roughness
- Being tested
- Profhilo® Body
- Keywords
- Skin laxity, Skin roughness, Profhilo Body, Hyaluronic Acid, Hybrid Cooperative Complexes
- Medical subject headings
- Cutis Laxa
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Profhilo® BodyDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Device: Profhilo® Body |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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.
Measured: 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)
Measured: 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.
Measured: 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
Measured: Day 0, Day 30, Day 120
Secondary outcomes (2)
Efficacy questionnaire
Self-assessment questionnaire regarding skin roughness and laxity of the treated areas, skin suppleness, skin smoothness, skin hydration, skin lifting, contour redefinition/remodeling (score: very marked; marked; medium; light; absent)
Measured: Day 30, Day 120
Treatment tolerance questionnaire
Self-assessment score: bad; poor; good; excellent
Measured: Day 30, Day 120
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Oct 2022
- Study start7 Nov 2022
- Primary completion8 Jun 2023
- Study completion8 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin LaxityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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).
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- IBSA Farmaceutici Italia Srl
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Derming SRL
- Responsible party
- Sponsor
- Investigators
- Adele Sparavigna, MD, Principal investigator, DERMING S.r.l., Clinical Research and Bioengineering Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05590364
- Sponsor's protocol ID
- E0122
- Status last verified
- Nov 2022
- First submitted
- 27 Sep 2022
- Last updated
- 28 Sep 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional, Post-marketing, Local, Mono-centric Study for Evaluation of Aesthetic Performance and Tolerance of an Injective Intradermal Treatment for the Skin Roughness and Laxity of Back of the Hands
- ClinicalTrials.gov ID
- NCT05590364
- Acronym / sponsor ID
- E0122
- Conditions
- Skin Laxity, Skin Roughness
- Keywords
- Skin laxity, Skin roughness, Profhilo Body, Hyaluronic Acid, Hybrid Cooperative Complexes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- IBSA Farmaceutici Italia SrlIndustry (pharma, biotech, devices)
- Collaborators
- Derming SRL
- Study start
- 7 Nov 2022 (actual)
- Primary completion
- 8 Jun 2023 (actual)
- Study completion
- 8 Jun 2023 (actual)
- First posted
- 21 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Open, monocentric. 3 visits, 55 subjects.
Primary endpoint of the study is the evaluation of performance and tolerance of Profhilo Body (3ml) treatment in the back of the hands ( or dorsum of the hands). Secondary endpoint is self-assessment questionnaire by both doctors and volunteers.
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. - IBSA Farmaceutici Italia S.r.l. - ITALY. The principle component is cross-linked Hyaluronic Acid of non-animal origin, produced by bacterial fermentation.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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).
| Arm | Type | Receives |
|---|---|---|
| Profhilo® Body treatment group | Experimental | Device: Profhilo® Body1.5 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (26 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Profhilo® BodyDosage 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. | Device | Profhilo® Body treatment group |
Primary outcome
Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection
Time frame: Day 0, Day 30, Day 120
Visual score from 1 (no roughness and flaccidity) to 5 (very severe roughness and flaccidity)
Change from Baseline of Skin density (profilometry) at 30 days and at 120 days post-injection
Time frame: Day 0, Day 30, Day 120
A picture of the skin is taken thanks to Primos compact portable device (GFMesstechnik) and a 3D representation is elaborated by Primos software.
Change from Baseline of Superficial and deep skin plastoelasticity at 30 days and at 120 days post-injection
Time frame: Day 0, Day 30, Day 120
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)
Change from Baseline of Tissue dielectric constant value of superficial and deep skin layers at 30 days and at 120 days post-injection
Time frame: Day 0, Day 30, Day 120
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.
Change from Baseline of Photographic evaluation at 30 days and at 120 days post-injection
Time frame: Day 0, Day 30, Day 120
2D pictures of the dorsum of both hands are taken in order to support the aesthetic result assessment
2 secondary outcomes
Efficacy questionnaire
Time frame: Day 30, Day 120
Treatment tolerance questionnaire
Time frame: Day 30, Day 120
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Sep 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Adele Sparavigna, MD principal investigator
DERMING S.r.l., Clinical Research and Bioengineering Institute
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Profhilo® Body in people with Skin Laxity and Skin Roughness, run by IBSA Farmaceutici Italia Srl at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 26 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 28 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline of Skin Roughness and flaccidity at 30 days and at 120 days post-injection (time frame: Day 0, Day 30, Day 120). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Sep 2023.