Skin AgingNCT05030051
A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging
A study testing SkinPen Precision System in people with Skin Aging, run by Crown Laboratories, Inc. at 1 site in United States.
Trial summary
This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Read more about this study
- Who is it for?
- Ages 50 to 75 years
- Conditions the study is for
- Skin Aging
- What is being tested?
- SkinPen Precision System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Mar 2021to 30 Nov 2022
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Men and women 50 to 75 years of age in 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 childbearing 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 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).
- Individuals who have significant scarring in the area(s) to be treated.
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- 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.
- 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)
- 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.
About this study
This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.
Read the detailed description
A total of 18 subjects will be enrolled in this study. These patients will be treated three times over the dorsum of the hand from the wrist to the knuckles each month for three months, followed by one follow-up visit at 3-months post-treatment.
Blueberry and Crown Laboratories will be responsible for recruitment efforts. Subjects will be numbered sequentially in the order in which they qualify for entry into the study.
3.2 Primary Endpoints • Clinician's global aesthetic improvement assessment (CGAIS) at 3-months post-treatment.
3.3 Secondary Endpoints
- Subject's global aesthetic improvement assessment (SGAIS) at 3-months post-treatment.
- Monitoring of adverse events throughout the course of the study. Safety Subject diaries will be monitored for resolution of anticipated treatment responses.
3.4 Exploratory Endpoints
- Bioinstrumentation: TEWL, hydration, elasticity, skin thickness measurements at each visit.
- Conditions
- Skin Aging
- Being tested
- SkinPen Precision System
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SkinPen Precision SystemDevice
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 Crown Laboratories 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. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit.
| Study group | Role | What they receive |
|---|---|---|
| SkinPen Precision System | Experimental | This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre- and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessment will be characterized using a clinician assessment scale at the 3 month post-treatment visit. Receives: Device: SkinPen Precision System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinician's global aesthetic improvement assessment (CGAIS)
This scale should be completed:
- Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the dorsal hand and final visit
Rating Description
- Very Much Improved: Optimal cosmetic result in this subject.
- Much Improved: Marked improvement in appearance from the initial condition, but not completely optimal for this subject.
- Improved: Obvious improvement in appearance from initial condition, but a re-treatment is indicated.
- No Change: The appearance is essentially the same as the original condition.
- Worse: The appearance is worse than the original condition.
Measured: 3-Month Post Treatment
Secondary outcomes (1)
Subject's global aesthetic improvement assessment (SGAIS)
At final visit, Subjects will be presented with Baseline and Visit 4 Photographs to complete this assessment.
Rating 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 initial condition.
- No Change: The appearance is essentially the same as the original condition.
- Worse: The appearance is worse than the original condition.
Measured: 3-Month Post Treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Sep 2021
- Study start12 Mar 2021
- Primary completion30 Jun 2022
- Study completion30 Nov 2022
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
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Crown Laboratories, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05030051
- Sponsor's protocol ID
- CL-HAS-21-03
- Status last verified
- Dec 2023
- First submitted
- 26 Aug 2021
- Last updated
- 18 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Skinpen on Male and Female Subjects' Dorsal Hands as a Treatment of Hand Aging
- ClinicalTrials.gov ID
- NCT05030051
- Acronym / sponsor ID
- CL-HAS-21-03
- Conditions
- Skin Aging
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Crown Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 12 Mar 2021 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Nov 2022 (actual)
- First posted
- 1 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre-and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessments will be characterized using a clinician assessment scale at the 3-month post-treatment visit.
Detailed description
A total of 18 subjects will be enrolled in this study. These patients will be treated three times over the dorsum of the hand from the wrist to the knuckles each month for three months, followed by one follow-up visit at 3-months post-treatment.
Blueberry and Crown Laboratories will be responsible for recruitment efforts. Subjects will be numbered sequentially in the order in which they qualify for entry into the study.
3.2 Primary Endpoints • Clinician's global aesthetic improvement assessment (CGAIS) at 3-months post-treatment.
3.3 Secondary Endpoints
- Subject's global aesthetic improvement assessment (SGAIS) at 3-months post-treatment.
- Monitoring of adverse events throughout the course of the study. Safety Subject diaries will be monitored for resolution of anticipated treatment responses.
3.4 Exploratory Endpoints
- Bioinstrumentation: TEWL, hydration, elasticity, skin thickness measurements at each visit.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SkinPen Precision System | Experimental | Device: SkinPen Precision SystemThis proof of concept study is being conducted over the course of 60 days followed by a 3-month post-treatment visit to assess the efficacy and tolerability of the Sponsor's SkinPen device when used to treat men and women with signs of aging on the dorsum of the hands. Overall assessment of clinical outcome and safety will be based on the evaluation of pre- and post-treatment photos comparing baseline to final visit. The subject's assessment of satisfaction will also be evaluated at Visit 3 and Visit 4. Finally, both the clinician's and subject's assessment will be characterized using a clinician assessment scale at the 3 month post-treatment visit. |
Who may qualify
- Ages
- 50 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Men and women 50 to 75 years of age in 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 (42 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 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).
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 Precision SystemMicroneedling 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 Crown Laboratories 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. We hypothesize that the SkinPen device will produce a significant improvement in dorsal hand appearance at 3 month post treatment visit, when compared with baseline scores. The assessments will be based on the Clinician's Global Aesthetic Improvement Scale, and the Subject's Global Aesthetic Improvement Scale at the 3 month post treatment visit. | Device | SkinPen Precision System |
Primary outcome
Clinician's global aesthetic improvement assessment (CGAIS)
Time frame: 3-Month Post Treatment
This scale should be completed: • Based on a live assessment of the subject while referring to the subject's pre-treatment photographs of the dorsal hand and final visit Rating 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 initial condition, but a 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.
1 secondary outcome
Subject's global aesthetic improvement assessment (SGAIS)
Time frame: 3-Month Post 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 18 Dec 2023.
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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 SkinPen Precision System in people with Skin Aging, run by Crown Laboratories, Inc. 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 42 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 18 Dec 2023. 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 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?
Clinician's global aesthetic improvement assessment (CGAIS) (time frame: 3-Month Post Treatment). 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 18 Dec 2023.