Subjects Displaying Facial AgeingNCT06032286
Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles
A study testing Skinstylus microneedling device in people with Subjects Displaying Facial Ageing, run by Beauty Health at 2 sites in United States.
Trial summary
To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in reducing the appearance of facial wrinkles.This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90. Read more about this study
- Who is it for?
- Ages 35 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Subjects Displaying Facial Ageing
- What is being tested?
- Skinstylus microneedling device
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 51 participants
- Where
- 2 sitesUnited States
- Study dates
- 8 Sep 2023to 9 May 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 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy male \& females; 35 to 75 years of age with signs of facial aging.
- Fitzpatrick I-VI phototype skin types.
- Volunteers with wrinkle grading of 1 to 4 according to Lemperle (2001) wrinkle grading scale.
- Volunteers with a laxity grading of 1-3.5 according to Alexiandes Armenakas (2010) grading scale.
- Written informed consent is given.
- Females of childbearing potential (FOCBP) and females who are premenses must be willing to practice effective contraception for the duration of the study. (Effective contraception is defined as stabilized on oral contraceptive for at least 3 months, intrauterine device, condom with spermicide, diaphragm with spermicide, implant, NuvaRing, injection, transdermal patch or abstinence.)
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- Females on birth control pills must have taken the same type of pill for at least 3 months prior to entering the study and must not change type during the study.
- Those who have used birth control pills in the past must have discontinued usage at least 3 months prior to the start of the study.
- Volunteers agree NOT to use any topical agents containing active ingredients such as retinol, glycolic acid in the treatment area, during the study period.
- Volunteers agree NOT to undergo any aesthetic treatments (such as Botox, fillers, microdermabrasion, laser surfacing etc.) in the treatment area, during the study period.
Who cannot join
- Volunteers have used a topical anti-aging product containing active ingredients within 4 weeks of commencing the study.
- Volunteers suffer from Hemophilia or other clotting/bleeding disorders.
- Volunteers taking anticoagulant therapy, e.g., warfarin, heparin.
- Volunteers who have used aspirin continuously in the last 2 weeks.
- Volunteers with active acne vulgaris of the face.
- Volunteers who have stopped taking birth control pills within the last 3 months.
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- Volunteers suffer from uncontrolled diabetes mellitus.
- Volunteers with known malignancy and/or undergoing chemotherapy, radiotherapy, or high doses of corticosteroids.
- Volunteers suffer from keloid scars, Human Papilloma virus (HPV) or birth marks in the treatment area.
- Volunteers have a tendency for keloid scar formation.
- Volunteers suffer from eczema or skin rashes in the treatment area.
- Volunteers suffer from systemic infections such as hepatitis.
- Volunteers have known allergy to topical/local anesthetics.
- Volunteers have continuously used high dose NSAIDs for the last 2 weeks.
- Volunteers have undergone plastic surgery in the treatment area within the last 6 months.
- Volunteers have undergone filler injections in the treatment area within the last 6 months.
- Volunteers have received Botox or other neuromodulators injections in the treatment area within the last 6 months.
- Females who are pregnant, breast-feeding or who wish to become pregnant during the study period.
- Enrolled in another clinical trial during the same study period.
- Volunteer has a planned hospital admission and/or surgical procedure for an illness or disease which existed before enrolment into the clinical trial, and which may interfere with the course or outcome of the study.
- Volunteering has medical or psychological condition(s) associated with a risk of poor protocol compliance (e.g., alcoholism or drug abuse).
- Volunteer is undergoing or is likely to undergo other treatments.
Trial locations and contacts
2 sites in 1 country.
United States2 sites
Ablon Skin Institute
Manhattan Beach, California, 90266
West Dermatology Research Center
San Diego, California, 92121
About this study
To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in reducing the appearance of facial wrinkles.This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90.
Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a modified Alexiandes Armenakas (2010) grading scale.
Read the detailed description
This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90.
Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a modified Alexiandes Armenakas (2010) grading scale.
Physicians will grade treatment response on days, 90, 120 and finally on day 150 using a Global Aesthetic Improvement Scale (GAIS) Standard photography will be recorded at baseline and days 30, 60, 90, 120 and finally at day 150.
Subjects will complete diaries including self-assessment of treatment response, side effects \& downtime up to 7 days post treatment.
Subjects will assess treatment response on days 90, 120 and finally on day 150 using a Subject Global Aesthetic Improvement Scale (SGAIS).
Subjects will assess treatment response and satisfaction at baseline and day 150 using the Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q3) Patient reported outcome measure (PROM).
The number, type and severity of adverse events will be recorded during the duration of the study period.
At the end of the study period, photography will be assessed by three blinded physicians using the wrinkle grading scale developed by Lemperle (2001)
- Conditions
- Subjects Displaying Facial Ageing
- Being tested
- Skinstylus microneedling device
- Keywords
- Wrinkles, Facial ageing, Micro needling
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skinstylus microneedling deviceDevice
Microneedling, also known as percutaneous collagen induction (PCI), is a minimally invasive technique where small needles create microscopic wounds in the skin inducing collagen formation.
| Study group | Role | What they receive |
|---|---|---|
| Microneedling | Experimental | 4 microneedling sessions at baseline and days 30, 60 and 90. Receives: Device: Skinstylus microneedling device |
What is being measured
The primary outcome is the main question the study is designed to answer.
Wrinkle improvement
Mean improvement over baseline of one grade for wrinkles utilizing the Lemperle (2001) grading scale scores of the periorbital, cheek folds and glabellar lines 120 and 150 days after the first treatment.
The Lemperle Wrinkle Grading Scale, is used to assess the severity of facial wrinkles.
The scale divides the face into distinct facial areas (horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek folds, nasolabial folds, upper lip lines, corner of mouth line, marionette lines and chin crease). Each area is classified 0-5, (0-No wrinkles, 5-Very deep wrinkles).
Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001;108(6):1735-1750.
Measured: 120 and 150 days after the first treatment
Secondary outcomes (1)
Texture and laxity
Mean improvement over baseline of one grade for skin laxity and texture 120 and 150 days after the first treatment using a scale developed by Alexiandes Armenakas This is a modified texture and laxity grading scale adapted from the complete grading scale developed by Alexiandes Armenakas (2010). The scale is an 8 point descriptive scale (0-4, with 0.4 increments). Where 0 is no visible evidence of skin laxity or texture and 4 is severe skin laxity and skin roughness (texture)
Measured: 120 and 150 days after the first treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2023
- Study start8 Sep 2023
- Primary completion9 May 2024
- Study completion9 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Subjects Displaying Facial AgeingStudies 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
- Single group, all subjects will receive intervention.
- Masking
- None (open label)
- Enrolment
- 51 participants (actual)
Sponsor and investigators
- Lead sponsor
- Beauty Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06032286
- Sponsor's protocol ID
- ASIRC_SSMS_07-14-23
- Status last verified
- Aug 2024
- First submitted
- 4 Sep 2023
- Last updated
- 7 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No: Plan for data to be published in peer reviewed journal
Publications
Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
PubMed 11711957Alexiades-Armenakas M. A quantitative and comprehensive grading scale for rhytides, laxity, and photoaging. J Drugs Dermatol. 2006 Sep;5(8):808-9. No abstract available.
PubMed 16989197Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013 Apr;40(2):249-60. doi: 10.1016/j.cps.2012.12.001.
PubMed 23506765Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995 Jun;21(6):543-9. doi: 10.1111/j.1524-4725.1995.tb00259.x.
PubMed 7773602Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
PubMed 28796657Ablon G. Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.
PubMed 30214664
Study at a glance
From the registry record, last updated by the sponsor on 7 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of the Skinstylus Sterilock Microneedling System for the Treatment of Facial Wrinkles
- ClinicalTrials.gov ID
- NCT06032286
- Acronym / sponsor ID
- ASIRC_SSMS_07-14-23
- Conditions
- Subjects Displaying Facial Ageing
- Keywords
- Wrinkles, Facial ageing, Micro needling
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 51 participants (actual)
- Lead sponsor
- Beauty HealthIndustry (pharma, biotech, devices)
- Study start
- 8 Sep 2023 (actual)
- Primary completion
- 9 May 2024 (actual)
- Study completion
- 9 May 2024 (actual)
- First posted
- 11 Sep 2023 (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.
To assess the efficacy and safety of the Skin stylus Sterilock microneedling system in reducing the appearance of facial wrinkles.This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90.
Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a modified Alexiandes Armenakas (2010) grading scale.
Detailed description
This study is intended to be a single arm study. Suitable subjects who meet all inclusion criteria and consented will undergo 4 microneedling sessions at baseline and days 30, 60 and 90.
Subjects will be assessed at days 90, 120 and finally at day 150 by a physician utilizing the wrinkle grading scale developed by Lemperle (2001) and skin laxity and texture using a modified Alexiandes Armenakas (2010) grading scale.
Physicians will grade treatment response on days, 90, 120 and finally on day 150 using a Global Aesthetic Improvement Scale (GAIS) Standard photography will be recorded at baseline and days 30, 60, 90, 120 and finally at day 150.
Subjects will complete diaries including self-assessment of treatment response, side effects \& downtime up to 7 days post treatment.
Subjects will assess treatment response on days 90, 120 and finally on day 150 using a Subject Global Aesthetic Improvement Scale (SGAIS).
Subjects will assess treatment response and satisfaction at baseline and day 150 using the Facial Appearance, Health-Related Quality of Life and Adverse Effects (FACE-Q3) Patient reported outcome measure (PROM).
The number, type and severity of adverse events will be recorded during the duration of the study period.
At the end of the study period, photography will be assessed by three blinded physicians using the wrinkle grading scale developed by Lemperle (2001)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single group, all subjects will receive intervention.
| Arm | Type | Receives |
|---|---|---|
| Microneedling | Experimental | Device: Skinstylus microneedling device4 microneedling sessions at baseline and days 30, 60 and 90. |
Who may qualify
- Ages
- 35 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Healthy male \& females; 35 to 75 years of age with signs of facial aging.
- Fitzpatrick I-VI phototype skin types.
- Volunteers with wrinkle grading of 1 to 4 according to Lemperle (2001) wrinkle grading scale.
- Volunteers with a laxity grading of 1-3.5 according to Alexiandes Armenakas (2010) grading scale.
- Written informed consent is given.
Key exclusion criteria (22 listed)
- Volunteers have used a topical anti-aging product containing active ingredients within 4 weeks of commencing the study.
- Volunteers suffer from Hemophilia or other clotting/bleeding disorders.
- Volunteers taking anticoagulant therapy, e.g., warfarin, heparin.
- Volunteers who have used aspirin continuously in the last 2 weeks.
- Volunteers with active acne vulgaris of the face.
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 |
|---|---|---|
| Skinstylus microneedling deviceMicroneedling, also known as percutaneous collagen induction (PCI), is a minimally invasive technique where small needles create microscopic wounds in the skin inducing collagen formation. | Device | Microneedling |
Primary outcome
Wrinkle improvement
Time frame: 120 and 150 days after the first treatment
Mean improvement over baseline of one grade for wrinkles utilizing the Lemperle (2001) grading scale scores of the periorbital, cheek folds and glabellar lines 120 and 150 days after the first treatment. The Lemperle Wrinkle Grading Scale, is used to assess the severity of facial wrinkles. The scale divides the face into distinct facial areas (horizontal forehead lines, glabellar frown lines, periorbital lines, preauricular lines, cheek folds, nasolabial folds, upper lip lines, corner of mouth line, marionette lines and chin crease). Each area is classified 0-5, (0-No wrinkles, 5-Very deep wrinkles). Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001;108(6):1735-1750.
1 secondary outcome
Texture and laxity
Time frame: 120 and 150 days after the first treatment
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 7 Aug 2024.
- Background: PubMed 11711957Lemperle G, Holmes RE, Cohen SR, Lemperle SM. A classification of facial wrinkles. Plast Reconstr Surg. 2001 Nov;108(6):1735-50; discussion 1751-2. doi: 10.1097/00006534-200111000-00048.
- Background: PubMed 16989197Alexiades-Armenakas M. A quantitative and comprehensive grading scale for rhytides, laxity, and photoaging. J Drugs Dermatol. 2006 Sep;5(8):808-9. No abstract available.
- Background: PubMed 23506765Pusic AL, Klassen AF, Scott AM, Cano SJ. Development and psychometric evaluation of the FACE-Q satisfaction with appearance scale: a new patient-reported outcome instrument for facial aesthetics patients. Clin Plast Surg. 2013 Apr;40(2):249-60. doi: 10.1016/j.cps.2012.12.001.
- Background: PubMed 7773602Orentreich DS, Orentreich N. Subcutaneous incisionless (subcision) surgery for the correction of depressed scars and wrinkles. Dermatol Surg. 1995 Jun;21(6):543-9. doi: 10.1111/j.1524-4725.1995.tb00259.x.
- Background: PubMed 28796657Alster TS, Graham PM. Microneedling: A Review and Practical Guide. Dermatol Surg. 2018 Mar;44(3):397-404. doi: 10.1097/DSS.0000000000001248.
- Results publication: PubMed 30214664Ablon G. Safety and Effectiveness of an Automated Microneedling Device in Improving the Signs of Aging Skin. J Clin Aesthet Dermatol. 2018 Aug;11(8):29-34. Epub 2018 Aug 1.
- Individual participant dataSharing planned: No. Plan for data to be published in peer reviewed journal
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Skinstylus microneedling device in people with Subjects Displaying Facial Ageing, run by Beauty Health at 2 sites in United States.
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 10 inclusion and 22 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 7 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States. 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?
Wrinkle improvement (time frame: 120 and 150 days after the first treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06032286, which also lists 6 linked publications.
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 7 Aug 2024.