Skin AgingNCT06933225
Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics
A study testing WOW fusion Microneedling Device, 1.00 mm in people with Skin Aging, run by Circa Skin Ltd at 1 site in France.
Trial summary
Microneedling (MN), also referred to as collagen induction therapy, uses small needles to create mechanical injury to the skin. The basis of MN relies on physical trauma. It has been proposed that the trauma generated by needle penetration in the skin induces regeneration of the dermis The needles penetrate the… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Skin Aging
- What is being tested?
- WOW fusion Microneedling Device, 1.00 mm
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 33 participants
- Where
- 1 siteFrance
- Study dates
- 1 Sep 2025to 5 Jan 2026
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy subject.
- Sex: male and female
- Age: 18 years or older
- Subject seeking an improvement of her/his face aspect using an aesthetic procedure.
- Subject with mild to moderate wrinkles (grade 1, 2 or 3 on the 6-points Lemperle Scales) on at least 2 of the following area:
- Horizontal forehead lines
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- Periorbital lines
- Cheek folds
- Subject willing to abstain from other facial aesthetic procedure in the full face through the entire study duration.
- Subject having given their free, express, and informed consent.
- Subject psychologically able to understand the information related to the study, and to give their written informed consent.
- Subject registered with a social security scheme.
- Female of childbearing potential must use a medically accepted contraceptive method since at least 12 weeks before the beginning of the study and throughout the study.
- Female subjects of childbearing potential must have a negative pregnancy test at the inclusion.
Who cannot join
- 1. Subjects who are pregnant, nursing or intend to become pregnant during study participation.
- 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- 3. Subject in a social or sanitary establishment. 4. Subjects that are currently enrolled in another drug or device study. 5. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
- 6. Subjects with a history of allergies or hypersensitivity to any components or ingredients in the device (especially allergy to nickel or gold).
- 7. Subjects with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple and severe allergies.
- 8. Subjects that have any skin pathology or condition including tattooing or scarring that could interfere with the evaluation of the treatment areas.
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- 9. Subjects who suffer from rosacea, eczema, psoriasis, atopic dermatitis, sun-burned or broken skin, inflammatory or irritated skin conditions, active cold sores, moderate to severe acne, abscess, herpes, unhealed wound, cancerous or precancerous lesion on the face.or are taking any prescribed medication for their skin or any skin disease.
- 10. Subject with any skin or systemic disease (acute and/or chronic), in the previous year, likely to interfere with the measured parameters or to put the subject to an undue risk.
- 11. Subject with known history of or suffering from autoimmune disease and/or immune deficiency.
- 12. Subject predisposed to keloids or hypertrophic scarring. 13. Subjects who have a hemorrhagic (bleeding) disorder or hemostatic (bleeding) dysfunction.
- 14. Subject with pigmentation disorders (vitiligo, melasma,….). 15. Subjects who have had any form of collagen soft tissue treatment within the last 12 months.
- 16. Subject having resorbable filling product (e.g., hyaluronic acid) injections, an ultrasound-based treatment, a dermabrasion, a deep chemical peeling or other ablative procedure on the face within the past 12 months prior to study start and a facial surgery in the past 2 years.
- 17. Subject having received injections of permanent (e.g., acrylate polymers, silicone, polytetrafluoroethylene) or semi-permanent filling on the face (L Polylactic acid, Calcium Hydroxyapatite...).
- 18. Subject with subcutaneous retaining structure on the face (meshing, threads, gold strand).
- 19. Subjects having received botulinum toxin in the face within the 9 previous months.
- 20. Subject having received mesotherapy products in the face within the 6 previous months.
- 21. Subject having done a superficial or medium peeling or a superficial scrub on the face or having received LED or laser treatment on the face within the 2 previous months.
- 22. Subject having used cosmetic products with alpha hydroxy acids (AHA) in the previous month.
- 23. Subjects who are currently, or within the past 3 months, treated with any systemic immunosuppressive therapy including but not limited to chemotherapy agents or corticosteroids (including inhaled or insufflated corticosteroids).
- 24. Subjects who are currently, or within the past 3 months, treated with any topical OTC drug or prescription therapy on their face.
- 25. Subjects taking an antithrombotic, antiplatelet or other blood thinning medications in the past 3 months.
- 26. Subject taking food supplement with an effect on skin quality (collagen, DHEA, …) in the 3 previous months.
- 27. Subjects that have received an investigational drug or device within 30 days prior to entering this study.
- 28. Subject receiving any treatment that, in the opinion of the clinical investigator, may interfere with test results or put the subject to undue risk.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Open-Label Study to Evaluate the Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics
Microneedling (MN), also referred to as collagen induction therapy, uses small needles to create mechanical injury to the skin. The basis of MN relies on physical trauma. It has been proposed that the trauma generated by needle penetration in the skin induces regeneration of the dermis The needles penetrate the stratum corneum and create small holes known as micro-conduits with minimal damage to the epidermis.
MN therapy is widely used to improve the appearance of facial scars, stretch marks and rejuvenate photoaged skin. Recently, it has been shown that MN can improve skin wrinkles on the face. MN can be used alone or to increase absorption of topical medications, growth factors, or deliver radiofrequency directly to the dermis.
The product tested is a microneedling device with 20 micro-needles of 1.00 mm depth penetration. This microneedling device is considered as a medical device in the US but not in Europe, according to Appendix XVI of the European regulation on medical devices 2017/745 of 5 April 2017. It is not yet commercialized neither in Europe nor in US. This first-in-man, pilot, clinical study is designed to first confirm the cutaneous tolerance of the device and provide some first data on device performance. For this purpose, 33 subjects with mild to moderate wrinkles on the face and seeking improvement of his/her face aspect, will be treated on Day 0 and Day 30 with the microneedling device on the face. Follow-up visits will be done 30 and 60 days after first treatment. Treatment Site Reactions (TSR) and Adverse reactions (ARs) will be collected to evaluate the device safety. Change from baseline of wrinkle severity and Global Aesthetic Improvement Scale (GAIS) will be used to evaluate product performance. Subject evaluation will also be analysed, and photos will be taken to illustrate device effect.
- Conditions
- Skin Aging
- Being tested
- WOW fusion Microneedling Device, 1.00 mm
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WOW fusion Microneedling Device, 1.00 mmOther
One treatment session on the whole face, on D0 and second treatment on D30.
| Study group | Role | What they receive |
|---|---|---|
| WOW fusion Microneedling Device, 1.00 mm | Experimental | One treatment session on the whole face, on D0 and second treatment on D30. Receives: Other: WOW fusion Microneedling Device, 1.00 mm |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participant with treatment site reaction
evaluated on a scale from 0 (None) to 3 (Severe)
Measured: 30 days after Day 0 and 30 days after Day 30
Secondary outcomes (8)
Global Aesthetic Improvement Scale assessment (GAIS)
evaluated by the investigator. 5 point scale from 1 : very much improved to 5 worsening.
Measured: Day 30 and Day 60
Global Aesthetic Improvement Scale assessment (GAIS)
evaluated by the subject. 5 point scale from 1 : very much improved to 5 worsening.
Measured: Day 30 and Day 60
Lemperle Wrinkle Scales
Evaluated by the investigator. 6 point scale as follow :
0: No wrinkle
- Just perceptible wrinkles
- Shallow wrinkles
- Moderately deep wrinkles
- Deep wrinkles, well-defined edges
- Very deep wrinkles, redundant folds
Measured: Day 0, Day 30 and Day 60
Average roughness with fringe projection system
Average height of the roughness (average relief) = Rz Average roughness (average relief) = Ra Maximum height of the roughness (maximum relief amplitude) = Rz
will be calculated direclty from fringe projection system software
Measured: Day 30 and Day 60
Maximum height with fringe projection system
Measured: Day 30 and Day 60
Average height with fringe projection system
Measured: Day 30 and Day 60
Satisfaction of the injectors
Will be evaluated by a questionnaire on a 5 point scale : 1 very satisfied to 5 very dissatisfied
Measured: Day 0 and Day 30
Satisfaction of the subject
Will be evaluated by a questionnaire on a 5 point scale : 1 very statisfied to 5 verry dissatisfied
Measured: Day 30 and Day 60
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2025
- Study start1 Sep 2025
- Primary completion5 Jan 2026
- Study completion5 Jan 2026
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
- 33 participants (actual)
Sponsor and investigators
- Lead sponsor
- Circa Skin Ltd
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06933225
- Sponsor's protocol ID
- 22E1008
- Other IDs
- 2024-A01913-44
- Status last verified
- Apr 2026
- First submitted
- 8 Apr 2025
- Last updated
- 17 Apr 2026
- 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 17 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open-Label Study to Evaluate the Safety and Efficacy of a Microneedling Device Used in Facial Aesthetics
- ClinicalTrials.gov ID
- NCT06933225
- Acronym / sponsor ID
- 22E1008
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 33 participants (actual)
- Lead sponsor
- Circa Skin LtdUniversity, hospital or other
- Study start
- 1 Sep 2025 (actual)
- Primary completion
- 5 Jan 2026 (actual)
- Study completion
- 5 Jan 2026 (actual)
- First posted
- 18 Apr 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.
Microneedling (MN), also referred to as collagen induction therapy, uses small needles to create mechanical injury to the skin. The basis of MN relies on physical trauma. It has been proposed that the trauma generated by needle penetration in the skin induces regeneration of the dermis The needles penetrate the stratum corneum and create small holes known as micro-conduits with minimal damage to the epidermis.
MN therapy is widely used to improve the appearance of facial scars, stretch marks and rejuvenate photoaged skin. Recently, it has been shown that MN can improve skin wrinkles on the face. MN can be used alone or to increase absorption of topical medications, growth factors, or deliver radiofrequency directly to the dermis.
The product tested is a microneedling device with 20 micro-needles of 1.00 mm depth penetration. This microneedling device is considered as a medical device in the US but not in Europe, according to Appendix XVI of the European regulation on medical devices 2017/745 of 5 April 2017. It is not yet commercialized neither in Europe nor in US. This first-in-man, pilot, clinical study is designed to first confirm the cutaneous tolerance of the device and provide some first data on device performance. For this purpose, 33 subjects with mild to moderate wrinkles on the face and seeking improvement of his/her face aspect, will be treated on Day 0 and Day 30 with the microneedling device on the face. Follow-up visits will be done 30 and 60 days after first treatment. Treatment Site Reactions (TSR) and Adverse reactions (ARs) will be collected to evaluate the device safety. Change from baseline of wrinkle severity and Global Aesthetic Improvement Scale (GAIS) will be used to evaluate product performance. Subject evaluation will also be analysed, and photos will be taken to illustrate device effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| WOW fusion Microneedling Device, 1.00 mm | Experimental | Other: WOW fusion Microneedling Device, 1.00 mmOne treatment session on the whole face, on D0 and second treatment on D30. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Healthy subject.
- Sex: male and female
- Age: 18 years or older
- Subject seeking an improvement of her/his face aspect using an aesthetic procedure.
- Subject with mild to moderate wrinkles (grade 1, 2 or 3 on the 6-points Lemperle Scales) on at least 2 of the following area:
Key exclusion criteria (24 listed)
- 1. Subjects who are pregnant, nursing or intend to become pregnant during study participation.
- 2. Subject who had been deprived of their freedom by administrative or legal decision or who is under guardianship.
- 3. Subject in a social or sanitary establishment. 4. Subjects that are currently enrolled in another drug or device study. 5. Subject with an excessive consumption of alcohol (more than 2 glasses of wine per day) and/or tobacco (more than 10 cigarettes per day).
- 6. Subjects with a history of allergies or hypersensitivity to any components or ingredients in the device (especially allergy to nickel or gold).
- 7. Subjects with severe allergies manifested by a history of anaphylaxis, or history or presence of multiple and severe allergies.
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 |
|---|---|---|
| WOW fusion Microneedling Device, 1.00 mmOne treatment session on the whole face, on D0 and second treatment on D30. | Other | WOW fusion Microneedling Device, 1.00 mm |
Primary outcome
Participant with treatment site reaction
Time frame: 30 days after Day 0 and 30 days after Day 30
evaluated on a scale from 0 (None) to 3 (Severe)
8 secondary outcomes
Global Aesthetic Improvement Scale assessment (GAIS)
Time frame: Day 30 and Day 60
Global Aesthetic Improvement Scale assessment (GAIS)
Time frame: Day 30 and Day 60
Lemperle Wrinkle Scales
Time frame: Day 0, Day 30 and Day 60
Average roughness with fringe projection system
Time frame: Day 30 and Day 60
Maximum height with fringe projection system
Time frame: Day 30 and Day 60
Average height with fringe projection system
Time frame: Day 30 and Day 60
Satisfaction of the injectors
Time frame: Day 0 and Day 30
Satisfaction of the subject
Time frame: Day 30 and Day 60
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 17 Apr 2026.
- 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.
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 WOW fusion Microneedling Device, 1.00 mm in people with Skin Aging, run by Circa Skin Ltd at 1 site in France.
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 14 inclusion and 24 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 17 Apr 2026. 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 France. 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?
Participant with treatment site reaction (time frame: 30 days after Day 0 and 30 days after Day 30). 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 17 Apr 2026.