Microneedling and Serum for Acne

Overseen By COREY LOUIS HARTMAN

Age: 18 - 65

Sex: Female

Trial Phase: Phase 2 & 3

Sponsor: Equipmed USA LLC

Disqualifiers: Herpes, Bleeding disorders, Connective tissue, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new acne treatment using a microneedling device called Dermapen 4™ combined with a special serum, MG-CLR. The research aims to evaluate the effectiveness of this combination in improving acne over 12 weeks. As a single-arm study, all participants will receive the same treatment. Women aged 18-45 with mild to moderate acne and no recent acne treatments may qualify. Participants should also have clear facial skin without other conditions that might interfere with the trial. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in acne treatment.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but it does require that you haven't received any acne treatment for 1 month before starting. Also, you can't use any other products on your face during the study.

What prior data suggests that the Dermapen 4™ microneedling device is safe for treating acne?

Research has shown that microneedling with devices like the Dermapen 4™ is generally safe and well-tolerated. Studies indicate that microneedling often results in mild side effects, such as temporary redness and slight swelling, akin to a mild sunburn. These effects typically resolve within a few days.

The FDA has reviewed microneedling devices and considers them safe and effective for certain uses. The Dermapen 4™ is particularly noted for its safety and comfort, allowing for adjustable needle depths, which makes the treatment more precise and less painful.

Specific safety data for the MG-CLR serum is not provided. However, such serums are typically used to enhance the effects of microneedling and are usually well-tolerated. Overall, the combination of Dermapen 4™ and MG-CLR serum appears safe based on current evidence, though individual reactions may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for acne?

Researchers are excited about the combination of Dermapen 4™ and MG-CLR serum for treating acne because it offers a unique approach compared to standard treatments like topical creams, oral antibiotics, and retinoids. Unlike these conventional options, which often focus on reducing bacteria or inflammation, this treatment uses microneedling to create tiny channels in the skin. This allows the MG-CLR serum to penetrate deeper, potentially enhancing its effectiveness. This method not only targets acne at a deeper level but also promotes skin regeneration, which might lead to quicker and more noticeable improvements in skin texture and appearance.

What evidence suggests that the Dermapen 4™ microneedling device is effective for treating acne?

Research has shown that microneedling, such as using the Dermapen 4™, often outperforms traditional acne treatments like chemical peels and laser therapy. Studies found that about 18% of patients experienced a 75% to 100% improvement in their acne scars after microneedling. Additionally, 24.4% of patients noticed a 50% to 74% improvement, and 55% saw a 25% to 49% improvement. This treatment also boosts collagen production, aiding in skin repair and reducing acne scars. In this trial, using the Dermapen 4™ with MG-CLR serum may enhance these benefits, making it a promising option for treating acne. ^{4 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for individuals with acne who are looking to improve their skin condition. Specific eligibility criteria have not been provided, so it's best to contact the study organizers for detailed requirements.

Inclusion Criteria

Fitzpatrick skin phototype I to VI

I haven't treated my acne with any methods for the last month.

I am a woman aged between 18 and 45.

Exclusion Criteria

Subjects known to have bleeding and clotting disorders (self-declared)

I currently have an active cold sore infection.

Subjects known to have connective tissue disorders

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1 week

Treatment

Participants receive treatment with the Dermapen 4™ microneedling device and MG-CLR serum for acne over 12 weeks

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Dermapen 4™

Trial Overview The effectiveness of Dermapen 4™ microneedling device in combination with MG-CLR serum is being tested over a period of 12 weeks to treat acne.

How Is the Trial Designed?

Group I: A single arm, full face clinical study. Experimental Treatment 1 Intervention

Dermapen 4 in conjunction with MG-CLR serum

Who Is Running the Clinical Trial?

Equipmed USA LLC

Lead Sponsor

Trials

1

Recruited

10+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11499218/

Microneedling in Dermatology: A Comprehensive Review ... Comparative studies have demonstrated that microneedling is often more effective than traditional treatments, such as chemical peels and laser therapy, in ...

2. onlinelibrary.wiley.com onlinelibrary.wiley.com/doi/10.1111/jocd.14502

Safety and efficacy of microneedling technology in the ... 2.5 Outcome evaluation. The reduction of acne scars following the treatment with the Dermapen 4TM microneedling device was measured prior and ...

3. mdpi.com mdpi.com/2079-9284/11/6/193

Current Understanding of Microneedling Procedures for ... The results revealed a noticeable clinical improvement in the acne scars, accompanied by significant increases in collagen types 1, 3, and 7, and newly ...

4. dermatologytimes.com dermatologytimes.com/view/studies-support-microneedling-efficacy-acne-scarring

Studies support microneedling efficacy for acne scarring Nearly 18% of patients reported a 75% to 100% improvement in acne scarring; 24.4% reported a 50% to 74% improvement; and 55% perceived a 25% to ...

5. app.trialscreen.org app.trialscreen.org/trials/phase-2-3-full-face-to-evaluate-efficacy-dermapen-4-microneedling-device-trial-nct06602284

A Full Face Study to Evaluate the Efficacy of Dermapen 4™ ... Participants may experience an improvement in their acne condition through the use of the microneedling device and serum. Additionally, they will receive free ...

6. fda.gov fda.gov/medical-devices/aesthetic-cosmetic-devices/microneedling-devices

Microneedling Devices This means the FDA has reviewed data to support a reasonable assurance of the safety and effectiveness of these devices for these uses.

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10549865/

Study to determine the safety and efficacy of microneedling ... The data generated during the duration of this clinical study demonstrates that microneedling may have the potential to be a well‐tolerated ...

8. dermapenworld.com dermapenworld.com/en-us/blog/microneedling-risks-side-effects-downtime

Dermapen Microneedling Risks, Side Effects & Downtime Is a Dermapen Treatment Safe? Yes. Only our Authorised Treatment Providers perform Dermapen Treatments under strict sterile conditions. All treatment ...

9. dermapenworld.com dermapenworld.com/en-us/dermapen-professional/dermapen-microneedling-pens/dermapen-4

Dermapen 4™ Microneedling Pen It's pain free, quick, safe and very comfortable to work with, now offering an adjustable needle depth of 3mm makes it unbeatable. Danijela Schenker & Claudine ...