Acne VulgarisNCT05071274
A Proof of Concept Study to Evaluate the Efficacy and Tolerability of Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45
A study testing Skinpen Prescision System in people with Acne Vulgaris, run by Crown Laboratories, Inc. at 1 site in United States.
Trial summary
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Skinpen Prescision System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 31 participants
- Where
- 1 siteUnited States
- Study dates
- 15 Mar 2021to 18 Mar 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 18 to 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adult males and females, ages 18 through 45, at the time the ICF is signed.
- Clinical diagnosis of Acne Vulgaris
- Investigator's Global Assessment (IGA) Score 1,2 or 3
- Individuals willing to withhold aesthetic therapies to the areas of the face 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, facials, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not facial laser hair removal.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit. 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;
Show all 16Show fewer
- Without a uterus and/or both ovaries;
- Bilateral tubal ligation at least 6 months prior to study enrollment.
- Individuals of childbearing 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) at least 3 months prior to study enrollment;
- 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 the informed consent document.
- 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.
Who cannot join
- Individuals diagnosed with known allergies to facial or general skin care products.
- Individuals who have presence of an active systemic or local skin disease, other than Acne Vulgaris, 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 face (< 6 months).
Show all 49Show fewer
- Individuals who have significant scarring, other than atrophic acne scars, in the area(s) to be treated.
- IGA Score 0 or 4.
- Individuals who have a recent or current history of inflammatory skin disease other than Acne Vulgaris, infection, cancerous/pre-cancerous lesion, unhealed wound 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 within the past year;
- Non-ablative, rejuvenative laser or light treatment within the past 6 months;
- Surgical dermabrasion or deep facial peels within the past 6 months;
- Had a chemical peel, dermabrasion, non-ablative laser or fractional laser resurfacing of the face and neck within 6 months
- Individuals with a history of using the following prescription and over-the-counter medications:
- Accutane or other systemic retinoids within the past 6 months;
- Topical Retinoids or Steroids 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 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 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.
- Topical Acne treatments including over-the-counter preparations
- Topical anti-inflammatory agents, or
- Topical antibiotics
- 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, other than Acne Vulgaris, 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 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 are currently participating in any other study involving the use of investigational device or drugs at another research facility or doctor's office within 4 weeks prior to inclusion into the study.
- Individuals who have observable suntan, nevi, excessive hair, etc. or other dermal conditions on the face 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.
- Subjects who have received radiation therapy and/or anti-neoplastic agents within 90 days prior to baseline
Trial locations and contacts
1 site in 1 country.
About this study
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.
Read the detailed description
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.
There is currently no published medical or scientific literature demonstrating the effect of Microneedling on Acne Vulgaris.
The pathogenesis of acne is attributed to four major factors:
(i)sebaceous gland hyperplasia; (ii) abnormal follicular hyperkeratinization; (iii) Propionibacterium acnes; and (iv) inflammatory and immune reactions. Increased sebum secretion is a major cause associated with the development of acne. Conventional treatments include topical retinoids, benzoyl peroxide, azelaic acid, and oral antibiotics and retinoids. However, most of these treatments take a long time to achieve a cure, and, recently, increasing resistance to antibiotics and isotretinoin's teratogenic potential have limited the use of traditional treatment.
This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions.
- Conditions
- Acne Vulgaris
- Being tested
- Skinpen Prescision System
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Skinpen Prescision SystemDevice
Skinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only.
| Study group | Role | What they receive |
|---|---|---|
| SkinPen Precision System | Experimental | After a 15-minute acclimation to ambient temperature and humidity conditions, subjects will participate in bio instrumentation to assess for erythema and will participate in standard photography.
The Investigator will treat each subject's face from hairline to jawline with the SkinPen Precision System following instructions in the SKINPEN PRECISION SYSTEM INSTRUCTIONS with the following treatment of the face at depths of up to 1.5mm. Treatment depth will be recorded for each subject at every visit. Subjects will be dispensed a study provided diary and trained on compliance. Receives: Device: Skinpen Prescision System |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammatory and Non inflammatory Lesion count
The primary endpoint of the study is reduction of lesion count from Visit 1 (baseline) to Visit 5, in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesions.
Measured: Through the course of the study, 120 days
Secondary outcomes (1)
Investigators Global Assessment (IGA)
IGA:Score 1= almost clear, score 2 = mild severity, score 3 = moderate severity
Measured: Through the course of the study, 120 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2021
- Study start15 Mar 2021
- Primary completion18 Mar 2022
- Study completion18 Mar 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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
- This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions. The Investigator will also perform the IGA assessment. Subjects will be dispensed a Diary to record any new Adverse Events between visits. Subjects will be encouraged to contact the Study Investigator if any adverse events arise.
- Masking
- None (open label)
- Enrolment
- 31 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
- NCT05071274
- Sponsor's protocol ID
- CL-AC-21-02
- Status last verified
- Mar 2022
- First submitted
- 22 Sep 2021
- Last updated
- 28 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2022. 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 Microneedling With SkinPen in Female and Male Subjects With Facial Acne Vulgaris, Ages 18 Through 45
- ClinicalTrials.gov ID
- NCT05071274
- Acronym / sponsor ID
- CL-AC-21-02
- Conditions
- Acne Vulgaris
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 31 participants (actual)
- Lead sponsor
- Crown Laboratories, Inc.Industry (pharma, biotech, devices)
- Study start
- 15 Mar 2021 (actual)
- Primary completion
- 18 Mar 2022 (actual)
- Study completion
- 18 Mar 2022 (actual)
- First posted
- 8 Oct 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 single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.
Detailed description
This single-center, proof of concept trial is being conducted over the course of 42 days followed by a 2-month post-last treatment visit in order to assess the efficacy and tolerability of the Sponsor's SkinPen device in treating Acne Vulgaris on the face.
There is currently no published medical or scientific literature demonstrating the effect of Microneedling on Acne Vulgaris.
The pathogenesis of acne is attributed to four major factors:
(i)sebaceous gland hyperplasia; (ii) abnormal follicular hyperkeratinization; (iii) Propionibacterium acnes; and (iv) inflammatory and immune reactions. Increased sebum secretion is a major cause associated with the development of acne. Conventional treatments include topical retinoids, benzoyl peroxide, azelaic acid, and oral antibiotics and retinoids. However, most of these treatments take a long time to achieve a cure, and, recently, increasing resistance to antibiotics and isotretinoin's teratogenic potential have limited the use of traditional treatment.
This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- This proof of Concept study serves to evaluate the efficacy and tolerability of Microneedling with SkinPen in female and male Subjects with facial Acne Vulgaris, ages 18 through 45. Overall assessment of clinical outcome and safety will be based on clinic visits. The Investigator will apply an objective and precise assessment, the Lesion Count of inflammatory and non-inflammatory lesions. The Investigator will also perform the IGA assessment. Subjects will be dispensed a Diary to record any new Adverse Events between visits. Subjects will be encouraged to contact the Study Investigator if any adverse events arise.
| Arm | Type | Receives |
|---|---|---|
| SkinPen Precision System | Experimental | Device: Skinpen Prescision SystemAfter a 15-minute acclimation to ambient temperature and humidity conditions, subjects will participate in bio instrumentation to assess for erythema and will participate in standard photography. The Investigator will treat each subject's face from hairline to jawline with the SkinPen Precision System following instructions in the SKINPEN PRECISION SYSTEM INSTRUCTIONS with the following treatment of the face at depths of up to 1.5mm. Treatment depth will be recorded for each subject at every visit. Subjects will be dispensed a study provided diary and trained on compliance. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (16 listed)
- Adult males and females, ages 18 through 45, at the time the ICF is signed.
- Clinical diagnosis of Acne Vulgaris
- Investigator's Global Assessment (IGA) Score 1,2 or 3
- Individuals willing to withhold aesthetic therapies to the areas of the face 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, facials, laser treatments, and tightening treatments, etc.) for the duration of the study. Waxing and threading is allowed but not facial laser hair removal.
- Women of childbearing potential agree to take a urine pregnancy test at the Baseline visit. 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 (49 listed)
- Individuals diagnosed with known allergies to facial or general skin care products.
- Individuals who have presence of an active systemic or local skin disease, other than Acne Vulgaris, 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 Prescision SystemSkinpen Precision is an automated nonsurgical micro needling device designed for use by licensed health care practitioners or individuals directed by practitioners. The device incorporates a sterile Microneedle cartridge and Biosheath for single use only. | Device | SkinPen Precision System |
Primary outcome
Inflammatory and Non inflammatory Lesion count
Time frame: Through the course of the study, 120 days
The primary endpoint of the study is reduction of lesion count from Visit 1 (baseline) to Visit 5, in the inflammatory (papules and pustules) and non-inflammatory (open and closed comedones) lesions.
1 secondary outcome
Investigators Global Assessment (IGA)
Time frame: Through the course of the study, 120 days
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 28 Mar 2022.
- Individual participant dataSharing planned: Undecided
Related trials for Acne Vulgaris
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Not yet recruitingPhase 3
Evaluation of the Efficacy and Safety of Fractional CO₂ Laser With and Without Intradermal Botulinum Toxin A in the Treatment of Inflammatory Facial Acne Vulgaris.
Acne, Acne Papulopustulosa
RecruitingPhase 4
Safety, Tolerability, and Clinical Effectiveness of Adapalene/Clindamycin Phosphate Gel (Klenzit®-C) in Vietnamese Patients With Mild to Moderate Acne Vulgaris
Acne
RecruitingPhase 4
Comparing Nadifloxacin Plus Tretinoin Versus Clindamycin Plus Tretinoin Creams for Mild-to-Moderate Acne
Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
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 Prescision System in people with Acne Vulgaris, 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 16 inclusion and 49 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 28 Mar 2022. 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?
Inflammatory and Non inflammatory Lesion count (time frame: Through the course of the study, 120 days). 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 28 Mar 2022.