Skin AgingNCT06844760
Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Neck Area
A study testing Hyaluronic Acid (HA) in people with Skin Aging, run by Espad Pharmed at 1 site in Iran.
Trial summary
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement. Read more about this study
- Who is it for?
- Ages 35 to 60 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- Hyaluronic Acid (HA)
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteIran
- Study dates
- 4 Jul 2024to 24 Oct 2024
- 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 35 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age between 35 and 60 years (inclusive)
- The presence of visible signs of skin aging, mainly dry neck skin, rough neck skin, loss of elasticity and clear lines and wrinkles (grades 2, 3, and 4 based on the IBSA Neck Laxity Scale)
- Able to follow study instructions and likely to complete all required visits
- Signing the informed consent form and agreeing to the 6-month follow-up
Who cannot join
- Previous treatment with fillers containing hyaluronic acid in the neck area during the last year
- History of using RF, rejuvenating lasers or intense pulsed light in the last 6 months
- Having systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, liver and kidney failure.
- History of systemic use of drugs affecting the skin such as glucocorticoids, isotretinoin, immunomodulators and hormonal drugs in the last 3 months
- History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months
- History of using topical corticosteroids and retinoids in the last 4 weeks
Show all 16Show fewer
- Using topical cosmetic products containing anti-aging ingredients in the last 2 weeks
- Pregnant and lactating women
- History of active smoking during the last 2 years
- Major change in lifestyle including diet and physical activities and sun exposure during the study
- History of previous allergy to hyaluronic acid or lidocaine
- Any inflammation, active infection, unhealed old wound, and skin lesions in the injection area
- Using any anticoagulant product, NSAID, or any other drug that increases the risk of coagulation disorders, in the last 7 days
- History of anaphylactic shock
- Being prone to hypertrophic scar formation
- History of autoimmune disease or immune deficiency or using immunosuppressant drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
- Conditions
- Skin Aging
- Being tested
- Hyaluronic Acid (HA)
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hyaluronic Acid (HA)Device
Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
| Study group | Role | What they receive |
|---|---|---|
| Perleux body | Experimental | Not described Receives: Device: Hyaluronic Acid (HA) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Skin elasticity measured with Cutometer
Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit
Measured: weeks 8 and 16
Secondary outcomes (8)
Stratum corneum moisture
Change of stratum corneum moisture measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Measured: weeks 8 and 16
Transepidermal Water Loss (TEWL)
Change of TEWL measured by MPA 580 probes in the neck area at weeks 8 and 16 from the baseline visit
Measured: weeks 8 and 16
General neck condition
Improvement in the clear lines and wrinkles of the neck area according to the Institut Biochimique SA (IBSA) Neck Laxity Scale, with grade 1 being normal tissue tone without noticeable laxity and grade 5 being severe laxity with extreme sagging, using before and after photos, by an independent physician
Measured: weeks 8 and 16
Skin aging
Improvement in the clear lines and wrinkles of the neck area according to global aesthetic improvement scale (GAIS), with grade 1 being exceptional improvement and grade 5 being worsened, using before and after photos by an independent physician
Measured: weeks 8 and 16
Pain intensity
Pain intensity using the VAS (visual analogue scale) [from 0 (complete painlessness) to 10 (maximum pain imaginable)].
Measured: Day 0 and week 4
Participant satisfaction
Participant satisfaction by using the VAS [from 0 (complete dissatisfaction) to 10 (complete satisfaction)].
Measured: weeks 8 and 16
Participant evaluation
Evaluation of participants on the improvement of their skin condition in terms of increased hydration, firmness and radiance, by a questionnaire designed by us. The questionnaire consists of five yes-or-no questions.
Measured: weeks 8 and 16
Safety assessment
Assessment of adverse events following treatment
Measured: Day 0 and weeks 4, 8, 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Feb 2025
- Study start4 Jul 2024
- Primary completion24 Oct 2024
- Study completion24 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skin AgingStudies 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
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Espad Pharmed
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06844760
- Sponsor's protocol ID
- PERB.ESP.VL.IV.03
- Status last verified
- Mar 2025
- First submitted
- 8 Feb 2025
- Last updated
- 5 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Effectiveness and Safety of Stabilized Injectable Hyaluronic Acid (Perleux Body, Produced by Espad Pharmed Company) in the Rejuvenation, Hydration, and Elasticity Improvement of the Neck Area
- ClinicalTrials.gov ID
- NCT06844760
- Acronym / sponsor ID
- PERB.ESP.VL.IV.03
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Espad PharmedIndustry (pharma, biotech, devices)
- Study start
- 4 Jul 2024 (actual)
- Primary completion
- 24 Oct 2024 (actual)
- Study completion
- 24 Oct 2024 (actual)
- First posted
- 25 Feb 2025 (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.
This study aimed to evaluate the safety and effectiveness of stabilized Hyaluronic Acid Injection under the brand name Perleux body for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Primary objective: Elasticity (R0, R2, and R5) improvement from baseline in neck area at weeks 8 and 16 Hypothesis: Perleux body (produced by Espad Pharmed Co.) has acceptable efficacy and safety profile for neck skin rejuvenation, elasticity improvement, and hydration enhancement.
Secondary objectives: Effectiveness and safety assessment of Perleux body Study design: This is a phase IV, single-arm, and pre-post study Setting: Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Perleux body | Experimental | Device: Hyaluronic Acid (HA) |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Age between 35 and 60 years (inclusive)
- The presence of visible signs of skin aging, mainly dry neck skin, rough neck skin, loss of elasticity and clear lines and wrinkles (grades 2, 3, and 4 based on the IBSA Neck Laxity Scale)
- Able to follow study instructions and likely to complete all required visits
- Signing the informed consent form and agreeing to the 6-month follow-up
Key exclusion criteria (16 listed)
- Previous treatment with fillers containing hyaluronic acid in the neck area during the last year
- History of using RF, rejuvenating lasers or intense pulsed light in the last 6 months
- Having systemic diseases that affect skin health, such as vascular collagen diseases, diabetes, hypothyroidism, liver and kidney failure.
- History of systemic use of drugs affecting the skin such as glucocorticoids, isotretinoin, immunomodulators and hormonal drugs in the last 3 months
- History of taking supplements containing collagen, hyaluronic acid and vitamin C in the last 3 months
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 |
|---|---|---|
| Hyaluronic Acid (HA)Subjects will be treated with 2cc of Perleux body at baseline. After 4 weeks, a touch-up injection will be performed to achieve optimal improvement. | Device | Perleux body |
Primary outcome
Skin elasticity measured with Cutometer
Time frame: weeks 8 and 16
Change of elasticity parameters (R0, R2, and R5) at weeks 8 and 16 from the baseline visit
8 secondary outcomes
Stratum corneum moisture
Time frame: weeks 8 and 16
Transepidermal Water Loss (TEWL)
Time frame: weeks 8 and 16
General neck condition
Time frame: weeks 8 and 16
Skin aging
Time frame: weeks 8 and 16
Pain intensity
Time frame: Day 0 and week 4
Participant satisfaction
Time frame: weeks 8 and 16
Participant evaluation
Time frame: weeks 8 and 16
Safety assessment
Time frame: Day 0 and weeks 4, 8, 16
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 5 Mar 2025.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hyaluronic Acid (HA) in people with Skin Aging, run by Espad Pharmed at 1 site in Iran.
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 4 inclusion and 16 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 5 Mar 2025. 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 Iran. 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?
Skin elasticity measured with Cutometer (time frame: weeks 8 and 16). 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 5 Mar 2025.