WrinklesNCT03803059
Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
A study testing SkinPen Precision in people with Wrinkles, run by Bellus Medical, LLC at 1 site in United States.
Trial summary
This single-center, the clinical trial is being conducted over the course of 90 days followed by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck. Read more about this study
- Who is it for?
- Ages 35 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Wrinkles
- What is being tested?
- SkinPen Precision
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 35 participants
- Where
- 1 siteUnited States
- Study dates
- 31 Jan 2019to 10 Jan 2020
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 20% of subjects will have Fitzpatrick skin types IV-VI Individuals who grade a 4 or higher on the Fitzpatrick Wrinkle Scale Individuals that desire correction of their wrinkles Individuals willing to withhold aesthetic therapies to the areas of the neck being treated or judged to potentially impact results by the Investigator.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one monthly pregnancy test at the Sponsor's discretion. Women who are of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the baseline visit. Women must be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to the study;
- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment. Women of child bearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one month pregnancy test at the Sponsor's discretion. Women who are of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the baseline visit. Women must be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to the study;
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- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment.
- Individuals of child-bearing potential who use an acceptable method of contraception throughout the study. Acceptable methods of birth control include:
- Established use of hormonal methods of contraception (oral, injected, implanted, patch, or vaginal ring).
- Barrier methods of contraception with spermicide: condom or occlusive cap (diaphragm or cervical/vault caps) with spermicidal foam/gel/film/cream/suppository.
- Intrauterine device (IUD) or intrauterine system (IUS)
- Surgical sterilization (e.g., vasectomy that has been confirmed effective by sperm count check, tubal occlusion, hysterectomy, bilateral salpingectomy/oophorectomy)
- Abstinence from heterosexual intercourse, when this is in line with the preferred and usual lifestyle of the subject. Periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
- Individuals that are willing to provide written informed consent and are able to read, speak, write, and understand English.
- Individuals willing to sign a photography release.
- Willingness to cooperate and participate by following study requirements (including those outlined in section 5.5) for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
Who cannot join
- Individuals diagnosed with known allergies to facial or general skincare products.
- Individuals who have the presence of an active systemic or local skin disease that may affect wound healing.
- Individuals who have severe solar elastosis.
- Individuals with sensitivity to topical lidocaine.
- Individuals who have physical or psychological conditions unacceptable to the Investigator.
- Individuals who have a recent history of significant trauma to the areas to be treated (< 6 months).
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- Individuals who have significant scarring, other than acne scars, in the area(s) to be treated.
- Individuals who have severe or cystic active and clinically significant acne on the area(s) to be treated. Clinically significant acne is defined as a subject who has > 5 active inflammatory acne lesions (including acne conglobate, nodules, or cysts) in either the right or left treatment area.
- Individuals who have a recent or current history of inflammatory skin disease, infection, cancerous/pre-cancerous lesion, unhealed wound or clinically significant acne in the proposed treatment areas. Individuals who have a history of systemic granulomatous diseases, active or inactive, (e.g. Sarcoid, Wegeners, TB, etc.) or connective tissue diseases (e.g. lupus, dermatomyositis, etc.).
- Individuals who currently have or have a history of hypertrophic scars or keloid scars.
- Individuals who currently have cancerous or pre-cancerous lesions in the areas to be treated and/or with a history of skin cancer.
- Individuals who have the inability to understand instructions or to give informed consent.
- Individuals who have had microdermabrasion or glycolic acid treatment to the treatment area(s) within 1 month prior to study participation or who will have this treatment during the study.
- Individuals who have a history of chronic drug or alcohol abuse.
- Individuals undergoing concurrent therapy that, in the Investigator's opinion, would interfere with the evaluation of the safety or efficacy of the study device.
- Individuals who, in the Investigator's opinion, have a history of poor cooperation, noncompliance with medical treatment, or unreliability.
- Individuals who are current smokers or have smoked in the last 5 years.
- Individuals who have a history of the following cosmetic treatments in the area(s) to be treated:
- Skin tightening procedure within the past year;
- Injectable filler of any type within the past:
- 12 months for Hyaluronic acid fillers (e.g. Restylane)
- 12 months for Ca Hydroxyapatite fillers (e.g. Radiesse)
- 24 months for Poly-L-Lactic acid fillers (e.g. Sculptra)
- Ever for permanent fillers (e.g. Silicone, ArteFill)
- Neurotoxins within the past 3 months;
- Ablative resurfacing laser treatment;
- Non-ablative, rejuvenating laser or light treatment within the past 6 months;
- Surgical dermabrasion or deep facial peels;
- Had a chemical peel, dermabrasion, non-ablative laser, or fractional laser resurfacing of the neck within 4 weeks
- Individuals with a history of using the following prescription medications:
- Accutane or other systemic retinoids within the past 6 months;
- Topical Retinoids within the past 2 weeks;
- Prescription-strength skin lightening devices (e.g. hydroquinone, tretinoin, AHA, BHA and polyhydroxy acids, 4-hydroxyanisole alone or in combination with tretinoin, etc.) within 4 months;
- Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic medication is known to affect skin aging or dyschromia (devices containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, Giga white, lemon juice extract (topically), Emblica extract, etc.) within 2 weeks;
- Antiplatelet agents/Anticoagulants (Coumadin, Heparin, Plavix, chronic NSAID use); and/or
- Psychiatric drugs that in the Investigator's opinion would impair the subject from understanding the protocol requirements or understanding and signing the informed consent.
- Individuals who are nursing, pregnant, or planning to become pregnant during the study according to the subject self-report.
- Individuals having a health condition and/or pre-existing or dormant dermatologic disease on the face or body (e.g., psoriasis, rosacea, eczema, seborrheic dermatitis, vitiligo, hyper or hypo-skin pigmentation conditions such as post-inflammatory hyperpigmentation) that the Investigator or designee deems inappropriate for participation or could interfere with the outcome of the study.
- Individuals with a history of immunosuppression/immune deficiency disorders (including HIV infection or AIDS) or currently using immunosuppressive medications (e.g., azathioprine, belimumab, cyclophosphamide, Enbrel, Imuran, Humira, mycophenolate mofetil, methotrexate, prednisone, Remicade, Stelara.) and/or radiation as determined by study documentation.
- Individuals with uncontrolled diseases such as asthma, diabetes, hyperthyroidism, medically significant hypertension or hypothyroidism. Individuals having multiple health conditions may be excluded from participation even if the conditions are controlled by diet, medication, etc.
- Individuals with any planned surgeries, overnight hospitalization, and/or invasive medical procedures during the course of the study.
- Individuals who are currently participating in any other study involving the use of investigational devices or drugs or have participated in any clinical trial at UT Southwestern or at another research facility or doctor's office within 4 weeks prior to inclusion into the study.
- Individuals who have an observable suntan, nevi, excessive hair, etc. or other dermal conditions on the neck that might influence the test results in the opinion of the Investigator or designee.
- Individuals who have any condition, which in the opinion of the Investigator makes the patient unable to complete the study per protocol (e.g. patients not likely to avoid other facial cosmetic treatments; patients not likely to stay in the study for its duration because of other commitments, concomitant conditions, or past history; patients anticipated to be unreliable, or patients who have a concomitant condition that may develop symptoms that might confuse or confound study treatments or assessments).
- Individuals who started hormone replacement therapies (HRT) or hormones for birth control less than 3 months prior to study entry or who plan on starting, stopping, or changing doses of HRT or hormones for birth control during the study.
Trial locations and contacts
1 site in 1 country.
United States1 site
The University of Texas Southwestern Medical Center
Dallas, Texas, 75390-9132
About this study
Official title: A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
This single-center, the clinical trial is being conducted over the course of 90 days followed by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck.
Read the detailed description
A total of 32 subjects completed study participation.
At visit 1 (baseline), subjects were screened for eligibility criteria, and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.
On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's wrinkles of the neck with SkinPen Precision System at depths of up to 2.5mm.
During the post-treatment period, Clinical evaluations were conducted at visit 2 (day 1), visit 3 (day 30), visit 4 (day 60), visit 5 (day 90), visit 6 (1month post-treatment), and visit 7 (3 months post-treatment)
- Conditions
- Wrinkles
- Being tested
- SkinPen Precision
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinPen PrecisionDevice
Surgical instrument motors and accessories/attachments/Hydrogel
| Study group | Role | What they receive |
|---|---|---|
| Wrinkles of the Neck | Experimental | Microneedle treatment neck areas. Receives: Device: SkinPen Precision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale
Wrinkling in the neck region will be assessed according to the following definitions:
Class 0: No Wrinkles Class 1: Just perceptible wrinkle Class 2: Shallow wrinkles Class 3: Moderately deep wrinkle Class 4: Deep wrinkle, well-defined edges Class 5: Very deep wrinkle, redundant fold
Measured: Day 1 and 3 Month Post Treatment
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
This scale is completed in two steps:
- Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the neck, and
- Based on a comparison of the subject's pre-treatment photographs to the current post-treatment photographs of the neck.
Rating and its Description
1 --Very Much Improved: Optimal cosmetic result in this subject. 2--Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
3-Improved: Obvious improvement in appearance from the initial condition, but re-treatment is indicated.
4--No Change: The appearance is essentially the same as the original condition. 5--Worse: The appearance is worse than the original condition.
Measured: 3 Month Post Treatment
Secondary outcomes (10)
Subject Global Aesthetic Improvement Scale (SGAIS)
Rating and Description
- -Very Much Improved: Optimal cosmetic result.
- -Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal.
- -Improved: Obvious improvement in appearance from the initial condition.
- -No Change: The appearance is essentially the same as the original condition.
- -Worse: The appearance is worse than the original condition
Measured: 1 Month Post Treatment and 3 Month Post Treatment
Transepidermal Water Loss of the Left Neck by Biox Aquaflux
The severity of wrinkles is more due to increased UV exposure through the driver's side window on the left side of the face and neck, due to this reason, the Principal investigator performed the TEWL on the left side of the neck. This test was pre-specified in the protocol. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle.
Biox Aquaflux is used to measure transepidermal water loss (TEWL) measurements which evaluate barrier function of the skin epidermal layer to determine the progress of epidermal healing after treatment.
Day 1 will be used as a baseline to analyze the change from baseline. TEWL is measured in g/m2/h. Normal rates of TEWL - from 2.3 g/m2/h to 44 g/m2/h - are compromised due to injury, infection, and/or severe damage as in the case of burns A decrease inTEWL reflects less water loss and an improvement in the skin's barrier properties; an absence of a change in treate
Measured: Baseline, 3 Months post treatment
Vascular Density Measurements by Optical Coherence Tomography(OCT)
Vivosight, an Optical coherence tomography (OCT) device, is used to non-invasively gather topographical and histologic images of pre-and post-treated skin. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. OCT measurements of the vascular density are reported in percentage (%) and were performed on the neck at 100 microns, 200 microns, and 500 microns. Scores multiplied by 1000 for analysis.
An increase in value indicates an increase in thickness and vascular density and skin tissue density.
Measured: Baseline (Day 1) and 3-Month post Treatment
Skin Roughness Measurements by Optical Coherence Tomography(OCT)
Vivosight, an optical coherence tomography (OCT) device, was used to noninvasively gather topographical and histologic images of pre-and post-treated skin. This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle. Roughness measurements were calculated from the histologic images using RA and RZ. Skin roughness is measured in micro-meters.
Ra is the average roughness of a surface. Rz is the difference between the tallest "peak" and the deepest "valley" on the surface.
A decrease in value indicates a decrease in skin roughness when Baseline and 3 months post-treatment are compared.
Measured: Baseline (Day 1) and 3 Months post treatment
BTC 2000 Measurements- Energy Absorption
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar)
This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle.
BTC 2000 was used to measure energy absorption of the skin.
The units for these measurements are Energy absorption - mmHg*mm
Decrease in values for energy absorption will be seen as Improvement
Measured: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Skin Elasticity
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar)
This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle.
BTC 2000 was used to measure Elasticity values of the skin.
The units for these measurements are in % of the distance traveled in µm.
A decrease case in values for elasticity will be seen as an improvement after the treatments.
Measured: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Skin Deformations
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar)
This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle.
BTC 2000 was used to measure viscoelastic deformation, elastic deformation, and ultimate deformation values of the skin.
The units for these measurements are in mm.
A Decrease in values for these deformations will be seen as an Improvement.
Measured: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Stiffness
BTC-2000™ Features: High-Resolution Target Laser (µm) and negative pressure (mmHg \& mbar)
This procedure was performed 4-6 cm from the left lateral neck along the sternocleidomastoid muscle.
BTC 2000 was used for stiffness. Stiffness is measure in mmHg/mm and an increase in values of BTC measurements for stiffness would be seen as an improvement upon treatment.
Measured: Baseline (Day 1) and 3 month post treatment
Patient Satisfaction Questionnaires
Subjects completed a Sponsor-provided questionnaire regarding improvement in wrinkles, satisfaction with the treatment, and willingness to recommend the treatment to friends and family members
Measured: 1 month post treatment
Ultrasound Measurements
Ultrasound measurements were performed using a 75 MHz ultrasonic transducer interfaced to a DUB 6100 OEM System (Taberna Pro Medicum, Lüneburg, Germany). Density and skin thickness measurements were obtained from the scans and increases in these values suggest a thickening of the epidermal and dermal tissue.
Measured: Day 1, 3 Months post treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jan 2019
- Study start31 Jan 2019
- Primary completion10 Jan 2020
- Study completion10 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for WrinklesStudies 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
- 35 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bellus Medical, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Kenkel, MD, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03803059
- Sponsor's protocol ID
- Bellmed002
- Status last verified
- Jul 2021
- First submitted
- 9 Jan 2019
- Last updated
- 1 Dec 2021
- Results posted
- Yes, on ClinicalTrials.gov
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Publications
Alqam M, Wamsley CE, Hitchcock TM, Jones BC, Akgul Y, Kenkel JM. Efficacy and tolerability of a microneedling device for treating wrinkles on the face. J Cosmet Dermatol. 2023 Jan;22(1):206-213. doi: 10.1111/jocd.14985. Epub 2022 Jun 2.
PubMed 35403786
Study at a glance
From the registry record, last updated by the sponsor on 1 Dec 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Single-Center Trial to Evaluate the Efficacy and Tolerability of SkinPen on Male and Female Subjects' Wrinkles of the Neck
- ClinicalTrials.gov ID
- NCT03803059
- Acronym / sponsor ID
- Bellmed002
- Conditions
- Wrinkles
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 35 participants (actual)
- Lead sponsor
- Bellus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 31 Jan 2019 (actual)
- Primary completion
- 10 Jan 2020 (actual)
- Study completion
- 10 Jan 2020 (actual)
- First posted
- 14 Jan 2019 (actual)
- Results
- Posted 1 Dec 2021
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, the clinical trial is being conducted over the course of 90 days followed by 1-month and 6-month post-treatment visits in order to assess the efficacy and tolerability of the Sponsor's SkinPen device when used by men and women with the wrinkles of the neck.
Detailed description
A total of 32 subjects completed study participation.
At visit 1 (baseline), subjects were screened for eligibility criteria, and those who qualified either completed day 1 procedures at the same visit or returned to the clinic up to 14 days after visit 1 to complete day 1 procedures at visit 2.
On days 1, 30, 60, and 90, after completion of visit assessments, doctors or fellows at the testing facility (henceforth referred to as "clinic") treated each subject's wrinkles of the neck with SkinPen Precision System at depths of up to 2.5mm.
During the post-treatment period, Clinical evaluations were conducted at visit 2 (day 1), visit 3 (day 30), visit 4 (day 60), visit 5 (day 90), visit 6 (1month post-treatment), and visit 7 (3 months post-treatment)
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Wrinkles of the Neck | Experimental | Device: SkinPen PrecisionMicroneedle treatment neck areas. |
Who may qualify
- Ages
- 35 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (17 listed)
- At least 20% of subjects will have Fitzpatrick skin types IV-VI Individuals who grade a 4 or higher on the Fitzpatrick Wrinkle Scale Individuals that desire correction of their wrinkles Individuals willing to withhold aesthetic therapies to the areas of the neck being treated or judged to potentially impact results by the Investigator.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one monthly pregnancy test at the Sponsor's discretion. Women who are of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the baseline visit. Women must be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
- Postmenopausal for at least 12 months prior to the study;
- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment. Women of child bearing potential agree to take a urine pregnancy test at the Baseline visit and 6-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to one month pregnancy test at the Sponsor's discretion. Women who are of childbearing potential must have a negative urine pregnancy test result and must not be lactating at the baseline visit. Women must be willing and able to use an acceptable method of birth control (e.g. barrier methods used with a spermicidal agent, hormonal methods, IUD, surgical sterilization, abstinence) during the study. Women will not be considered of childbearing potential if one of the following conditions is documented on the medical history:
Key exclusion criteria (45 listed)
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 |
|---|---|---|
| SkinPen PrecisionSurgical instrument motors and accessories/attachments/Hydrogel | Device | Wrinkles of the Neck |
Primary outcome
Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale
Time frame: Day 1 and 3 Month Post Treatment
Wrinkling in the neck region will be assessed according to the following definitions: Class 0: No Wrinkles Class 1: Just perceptible wrinkle Class 2: Shallow wrinkles Class 3: Moderately deep wrinkle Class 4: Deep wrinkle, well-defined edges Class 5: Very deep wrinkle, redundant fold
Clinician's Global Aesthetic Improvement Assessment (CGAIS)
Time frame: 3 Month Post Treatment
This scale is completed in two steps: * Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the neck, and * Based on a comparison of the subject's pre-treatment photographs to the current post-treatment photographs of the neck. Rating and its Description 1 --Very Much Improved: Optimal cosmetic result in this subject. 2--Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject. 3-Improved: Obvious improvement in appearance from the initial condition, but re-treatment is indicated. 4--No Change: The appearance is essentially the same as the original condition. 5--Worse: The appearance is worse than the original condition.
10 secondary outcomes
Subject Global Aesthetic Improvement Scale (SGAIS)
Time frame: 1 Month Post Treatment and 3 Month Post Treatment
Transepidermal Water Loss of the Left Neck by Biox Aquaflux
Time frame: Baseline, 3 Months post treatment
Vascular Density Measurements by Optical Coherence Tomography(OCT)
Time frame: Baseline (Day 1) and 3-Month post Treatment
Skin Roughness Measurements by Optical Coherence Tomography(OCT)
Time frame: Baseline (Day 1) and 3 Months post treatment
BTC 2000 Measurements- Energy Absorption
Time frame: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Skin Elasticity
Time frame: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Skin Deformations
Time frame: Baseline (Day 1) and 3 month post treatment
BTC 2000 Measurements for Stiffness
Time frame: Baseline (Day 1) and 3 month post treatment
Patient Satisfaction Questionnaires
Time frame: 1 month post treatment
Ultrasound Measurements
Time frame: Day 1, 3 Months post treatment.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Dec 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 35403786Alqam M, Wamsley CE, Hitchcock TM, Jones BC, Akgul Y, Kenkel JM. Efficacy and tolerability of a microneedling device for treating wrinkles on the face. J Cosmet Dermatol. 2023 Jan;22(1):206-213. doi: 10.1111/jocd.14985. Epub 2022 Jun 2.
- 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.
Jeffrey Kenkel, MD principal investigator
University of Texas Southwestern Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing SkinPen Precision in people with Wrinkles, run by Bellus Medical, LLC at 1 site 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 17 inclusion and 45 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 1 Dec 2021. 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 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?
Yes. Results are posted in the registry (first posted 1 Dec 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Assessment of Wrinkle Severity Using the Lemperle Wrinkle Assessment Scale (time frame: Day 1 and 3 Month Post Treatment). The study lists 2 primary outcomes in all. 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 NCT03803059, which also lists 1 linked publication.
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 1 Dec 2021.