AcnePhase 2/3NCT06602284
A Full Face Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Addition with MG-CLR Serum for Acne Treatment Over 12 Weeks.
A Phase 2/3 study testing Dermapen 4™ in people with Acne, run by Equipmed USA LLC at 1 site in United States.
Trial summary
This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Acne
- What is being tested?
- Dermapen 4™
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteUnited States
- Study dates
- Oct 2024to Mar 2025
- Phase
- Phase 2/3
- 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
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Female subjects aged between 18-45 years (both ages inclusive)
- Fitzpatrick skin phototype I to VI.
- Subjects having IGA score of 2 and 3.
- Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
- Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
- Subjects who agree not to use any other product/treatment/home remedy/ except the provided products on their face during the study period
Who cannot join
- Subjects with known skin condition that may impact the assessment.
- Subjects with active Herpes labialis infection.
- Subjects known to have bleeding and clotting disorders (self-declared).
- Subjects known to have connective tissue disorders.
- Subjects with any other signs of significant local irritation or skin disease.
- Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
Trial locations and contacts
1 site in 1 country.
United States1 site
Skin Wellness Dermatology
Birmingham, Alabama, 35209
Jordan Rubin, 205.678.7518, jrubin@skinwellness.com
COREY LOUIS HARTMAN
About this study
Official title: A Full Face, Baseline Controlled Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Conjunction with MG-CLR Serum for Acne Treatment Over 12 Weeks.
This study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.
- Conditions
- Acne
- Being tested
- Dermapen 4™
- Keywords
- dermapen, microneedling, acne
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dermapen 4™Combination product
Dermapen 4™ conjunction with MG-CLR
| Study group | Role | What they receive |
|---|---|---|
| A single arm, full face clinical study. | Other | Dermapen 4 in conjunction with MG-CLR serum Receives: Combination Product: Dermapen 4™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Acne severity
Change in acne severity using the modified GAGS scale at all time points when compared to baseline.
Measured: 13 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2024
- Study startOct 2024 (estimated)
- Primary completionMar 2025 (estimated)
- Study completionMar 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AcneStudies 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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Equipmed USA LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06602284
- Sponsor's protocol ID
- SKIN/EMAC/2024-01
- Status last verified
- Sep 2024
- First submitted
- 16 Sep 2024
- Last updated
- 19 Sep 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- Yes
- Individual data sharing
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Full Face, Baseline Controlled Study to Evaluate the Efficacy of Dermapen 4™ Microneedling Device in Conjunction with MG-CLR Serum for Acne Treatment Over 12 Weeks.
- ClinicalTrials.gov ID
- NCT06602284
- Acronym / sponsor ID
- SKIN/EMAC/2024-01
- Conditions
- Acne
- Keywords
- dermapen, microneedling, acne
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- Equipmed USA LLCIndustry (pharma, biotech, devices)
- Study start
- Oct 2024 (estimated)
- Primary completion
- Mar 2025 (estimated)
- Study completion
- Mar 2025 (estimated)
- First posted
- 19 Sep 2024 (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 study is conducted to check how well the Dermapen 4™ microneedling device works with MG-CLR serum for treating acne over 12 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| A single arm, full face clinical study. | Other | Combination Product: Dermapen 4™Dermapen 4 in conjunction with MG-CLR serum |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Female subjects aged between 18-45 years (both ages inclusive)
- Fitzpatrick skin phototype I to VI.
- Subjects having IGA score of 2 and 3.
- Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
- Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
Key exclusion criteria (6 listed)
- Subjects with known skin condition that may impact the assessment.
- Subjects with active Herpes labialis infection.
- Subjects known to have bleeding and clotting disorders (self-declared).
- Subjects known to have connective tissue disorders.
- Subjects with any other signs of significant local irritation or skin disease.
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 |
|---|---|---|
| Dermapen 4™Dermapen 4™ conjunction with MG-CLR | Combination product | A single arm, full face clinical study. |
Primary outcome
Acne severity
Time frame: 13 weeks
Change in acne severity using the modified GAGS scale at all time points when compared to baseline.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2024.
- Individual participant dataSharing planned: Yes
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Dermapen 4™ in people with Acne, run by Equipmed USA 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 6 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 19 Sep 2024. 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.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Stene Marshal ((949) 798 6207, stene@dermapenworld.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acne severity (time frame: 13 weeks). 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 19 Sep 2024.