AgingNCT04136847
Study to Evaluate the Efficacy and Tolerability of the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging
A study testing SkinPen Precision in people with Aging, run by Bellus Medical, LLC at 1 site in United States.
Trial summary
Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood… Read more about this study
- Who is it for?
- Ages 50 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Aging
- 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
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jan 2020to 26 May 2020
- 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 50 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Men and women 50 to 75 years of age having general good health.
- Individuals deemed by the Investigator, visually, to have signs of hand aging (presence of skin laxity, age spots, trophic changes) on the dorsum of the hand.. Also, Subjects would have to be willing to undergo correction of these signs of aging.
- Individuals willing to withhold aesthetic therapies to the areas of the hand being treated or judged to potentially impact results by the Investigator (e.g. soft tissue fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL (intense pulsed light), peels, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not laser hair removal.
- Individuals that are willing to provide written informed consent
- Individuals willing to sign a photography release.
- Willingness to cooperate and participate by following study requirements for the duration of the study and to report any changes in health status or medications, adverse event symptoms, or reactions immediately.
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- Women of child bearing potential agree to take a urine pregnancy test at the Baseline visit and 3-months post-treatment or when deemed by Investigator and/or Sponsor. This may be changed to a 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 study;
- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment.
Who cannot join
- Individuals diagnosed with known allergies to general skin care products.
- Individuals who have 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 in the area(s) to be treated.
- Individuals who have a recent or current history of inflammatory skin disease, infection or unhealed wound.
- 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 one 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 five 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 three months;
- Ablative resurfacing laser treatment;
- Non-ablative, rejuvenative laser or light treatment within the past six months;
- Surgical dermabrasion;
- Had a chemical peel or dermabrasion, of the dorsum of the hand within four weeks
- Individuals with a history of using the following prescription medications:
- Accutane or other systemic retinoids within the past six months;
- Topical Retinoids within the past two 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 four months;
- Any anti-wrinkle, skin lightening devices, or any other device or topical or systemic medication known to affect skin aging or dyshcromia (devices containing alpha/beta/poly-hydroxy acids, vitamin C, soy, Q-10, hydroquinone; systemic or licorice extract (topically), Tego® Cosmo C250, gigawhite, lemon juice extract (topically), emblica extract, etc.) within two 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 subject self-report.
- Individuals having a health condition and/or pre-existing or dormant dermatologic disease on the 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 an uncontrolled disease 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 have observable suntan, nevi, excessive hair, etc. or other dermal conditions on the back of the hand 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 cosmetic treatments to the treatment area; 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 three 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 the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging
Microneedling is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Bellus Medical is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand.
Read the detailed description
SkinPen microneedling treatment of dorsal hand skin This is a single-site, non-randomized, non-controlled study designed to follow at least twenty
three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments. The sample size determination of this study is based on the recommendations of the sponsor. These patients will be treated four times over the dorsum of the hand from the wrist to the knuckles each month for four months, followed by two follow-up visits at 1-month and 3-months post-treatment. The acute effects of microneedling will be determined by subjective and objective analysis using standard and close-up photography. Additionally, the effects of this treatment will be analyzed at 1-month and 3-month post-treatment through clinician and subject assessments.
Subjects will be identified from Dr. Jeffrey Kenkel's clinical practice at the University of Texas Southwestern Medical Center. Subjects will be numbered sequentially in the order in which they qualify for entry into the study.
- Conditions
- Aging
- Being tested
- SkinPen Precision
- Keywords
- Signs of Hand Aging
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 |
|---|---|---|
| Hand Aging | Experimental | Microneedling treatment of the dorsum of the hands Receives: Device: SkinPen Precision |
What is being measured
The primary outcome is the main question the study is designed to answer.
Aesthetic Assessment of change
Clinician's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''
Measured: 6 months
Aesthetic Assessment
Subject's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''
Measured: 6 months
Secondary outcomes (5)
Adverse Events
Monitoring of adverse events throughout the course of the study.
Measured: 6 months
Skin density
Ultrasound Imaging System
Measured: 6 months
Skin Firmness
BTC 2000
Measured: 6 months
Assessments of aging signs
Measurements acquired by the VISIA Complexion Analysis System
Measured: 6 months
Treatment satisfaction assessment
Patient Satisfaction Questionnaire
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2019
- Study start10 Jan 2020
- Primary completion26 May 2020
- Study completion26 May 2020
Why it stopped: Due to COVID 19 the Study did not start enrolling
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Model description
- At least twenty three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments.
- Masking
- None (open label)
- Enrolment
- 0 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, UTSW
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04136847
- Sponsor's protocol ID
- Bellmed003
- Status last verified
- Jun 2021
- First submitted
- 17 Oct 2019
- Last updated
- 7 Jun 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 7 Jun 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 the SkinPen on Male and Female Subjects' Dorsal Hands as a Treatment for Signs of Hand Aging
- ClinicalTrials.gov ID
- NCT04136847
- Acronym / sponsor ID
- Bellmed003
- Conditions
- Aging
- Keywords
- Signs of Hand Aging
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Due to COVID 19 the Study did not start enrolling
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Bellus Medical, LLCIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2020 (actual)
- Primary completion
- 26 May 2020 (actual)
- Study completion
- 26 May 2020 (actual)
- First posted
- 23 Oct 2019 (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 is a relatively new, minimally invasive technique originally developed for skin rejuvenation. Controlled micro-injury to the dermis via the application of several small needles connected to a motorized device stimulates the wound healing process, resulting in the formation of new tissue and blood vessels. The SkinPen by Bellus Medical is an FDA-cleared microneedling device proven to improve the appearance of acne scars This study evaluates the clinical performance of the SkinPen device for the treatment of signs of aging on the back of the hand.
Detailed description
SkinPen microneedling treatment of dorsal hand skin This is a single-site, non-randomized, non-controlled study designed to follow at least twenty
three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments. The sample size determination of this study is based on the recommendations of the sponsor. These patients will be treated four times over the dorsum of the hand from the wrist to the knuckles each month for four months, followed by two follow-up visits at 1-month and 3-months post-treatment. The acute effects of microneedling will be determined by subjective and objective analysis using standard and close-up photography. Additionally, the effects of this treatment will be analyzed at 1-month and 3-month post-treatment through clinician and subject assessments.
Subjects will be identified from Dr. Jeffrey Kenkel's clinical practice at the University of Texas Southwestern Medical Center. Subjects will be numbered sequentially in the order in which they qualify for entry into the study.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- At least twenty three (23) qualified and consenting subjects treated with 4 Skinpen microneedling treatments.
| Arm | Type | Receives |
|---|---|---|
| Hand Aging | Experimental | Device: SkinPen PrecisionMicroneedling treatment of the dorsum of the hands |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women 50 to 75 years of age having general good health.
- Individuals deemed by the Investigator, visually, to have signs of hand aging (presence of skin laxity, age spots, trophic changes) on the dorsum of the hand.. Also, Subjects would have to be willing to undergo correction of these signs of aging.
- Individuals willing to withhold aesthetic therapies to the areas of the hand being treated or judged to potentially impact results by the Investigator (e.g. soft tissue fillers and/or any resurfacing procedures, botulinum toxin, injectable fillers, microdermabrasion, IPL (intense pulsed light), peels, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not laser hair removal.
- Individuals that are willing to provide written informed consent
- Individuals willing to sign a photography release.
Key exclusion criteria (44 listed)
- Individuals diagnosed with known allergies to general skin care products.
- Individuals who have 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.
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 | Hand Aging |
Primary outcome
Aesthetic Assessment of change
Time frame: 6 months
Clinician's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''
Aesthetic Assessment
Time frame: 6 months
Subject's global aesthetic improvement assessment (CGAIS) , a 5 point grading scale where 1 is ''Very Much Improved'' and 5 is ''Worse''
5 secondary outcomes
Adverse Events
Time frame: 6 months
Skin density
Time frame: 6 months
Skin Firmness
Time frame: 6 months
Assessments of aging signs
Time frame: 6 months
Treatment satisfaction assessment
Time frame: 6 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jun 2021.
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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
UTSW
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 Aging, 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 10 inclusion and 44 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: withdrawn, as of the sponsor's last update on 7 Jun 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?
The study was withdrawn before enrolling participants, so there are no results.
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?
Aesthetic Assessment of change (time frame: 6 months). 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?
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 Jun 2021.