Dermapen microneedle treatment for acne scars and enlarged pores

Q: Is Derma Pen really effective in treating acne scars?

Nine systematic RCT reviews concluded that microneedling is effective for acne scars, but the device is multi-faceted, not specifically Dermapen, and the authors noted that there is no standard method and more work is needed.[1] The Equipmed DP4 model passed the US FDA's 510(k) review with an indication for facial acne scars.[3]

Q: Does it help with enlarged pores or stretch marks?

From the research, no studies found that used microneedling alone for enlarged pores. As for stretch marks, a review of 100 articles concluded that there is no standard method and that using multiple methods together is generally better.[4] Neither of these is included in the readable FDA indications.[3]

Q: Can it be used with PRP or exosome serums?

The clinic's page does not specify which products it is compatible with. Safety reviews have cautioned against using it with products not approved for use on the skin.[2] Always ask for the product name, manufacturer, and registration status before agreeing.

Q: Is the clinic's equipment registered with the FDA (Food and Drug Administration) or the Thai FDA?

The US FDA has a 510(k) list for the Equipmed USA DP4[3], but it does not specify that the clinic's device is this model, and the US FDA is not equivalent to the Thai FDA registration. No verifiable Thai FDA registration information was found, so the clinic should request the registration number.

Derma Pen Microneedle (Dermapen)

Derma Pen is a microneedling service offered by Fresh Code Clinic. This page summarizes what the clinic states, the supporting evidence, the registration status of the Dermapen device, and things to ask before starting.

Key Takeaway

The best evidence is acne scars: a systematic review of 9 RCTs concluded that microneedling is effective, but it comes in many variations and there is no standardized method.^[1]
Enlarged pores and stretch marks are not among the readable FDA indications, and no evidence of microneedling specifically for pores was found.^[3]^[4]
The Equipmed DP4 model (Dermapen 4, as the name suggests) has a 510(k) rating from the US FDA for acne scars, I–V skin types, and ages 22 and up. However, it is not registered with the Thai FDA, and it is unknown whether the clinic's device is this model.^[3]
Side effects include temporary redness, swelling, and hyperpigmentation. Granuloma scarring is more common in darker skin tones. Use with caution when combining with products not approved for topical application.^[2]
You should ask about the device model, FDA registration number, compatible products, needle depth, and number of sessions.

What is a Derma Pen (Dermapen)?

According to the clinic, Derma Pen, or Micro-needling, involves using a pen-shaped device with small needles to press onto the skin. The doctor can adjust the needle depth. It's used to treat acne scars and enlarged pores. The needles have a diameter of 0.25 mm, a length of 0.25–2 mm, and the speed is adjustable from 20–90 strokes per minute.

The principle of microneedling is to repeatedly puncture the skin with a sterile needle to break up the fibrous tissue that holds the scar tissue in place. A systematic review has been conducted including randomized trials on acne scars.^[1] However, the information provided by the clinic did not specify the manufacturer, model, or registration number of the "Dermapen" machine actually used. Therefore, it cannot be confirmed which model it is or what registration it has.

The results indicated by the clinic, versus the evidence obtained through examination.

The results indicated by the clinic.	Examinable evidence
Treats acne scars/blemishes, gradually reducing their depth.	A systematic review of 9 RCTs concluded that microneedling is effective for acne scars both alone and in combination with other methods, and no serious side effects were observed in those studies. However, the authors noted that there is no standard method yet and larger, longer-term studies are needed.^[1] The DP4 variant of Equipmed has passed the US FDA's 510(k) review with indications for facial acne scars.^[3]
Stimulates collagen, elastin, and growth factor.	The abstracts I read did not measure these mechanisms; they only examined superficial effects (scars). No evidence directly investigating the mechanisms was found in the sources I read.
Helps reduce pore size and tighten facial skin.	Based on my research, I found no studies using microneedling alone for enlarged pores or skin tightening. The studies found involved using microneedling in combination with botulinum toxin (I didn't read the specifics), and this isn't included in the available FDA indications.
Treating skin cracks (stretch marks)	A review of 100 articles concluded that there is no standard treatment for stretch marks. Common methods yield similar results, and combining multiple methods is often better than using a single method. The effectiveness of microneedling was not specifically examined in the abstracts.^[4] Stretch marks are not included in the FDA indications listed.^[3]
Faster than a dermaroller, with a consistent speed, resulting in precise hole size.	No comparative studies examining this issue were found in the sources read (the review above included several types of microneedling devices and did not indicate that the pen-type was superior).

The cited study is a review that included various microneedling devices, not a direct comparison with the Dermapen model used in clinics. Therefore, the results cannot be interpreted as specific to clinic-specific expectations, and verifiable data on the number of sessions required was not found.

Dermapen device and its registration status.

In the US FDA, item 510(k) of Equipmed USA, LLC (K221070, decided December 20, 2022) is classified as a Class II cosmetic microneedling device. Its indication is to improve facial acne scars in adults 22 years of age and older with Fitzpatrick I–V skin.^[3] The model name DP4 is likely related to Dermapen 4, but this has not been directly confirmed with the manufacturer's documentation. Furthermore, a search of the Equipmed database did not reveal any other microneedling models.

The clinical specifications (needle length 0.25–2 mm, speed 20–90 strokes per minute) do not specify a particular model and are not compared to FDA documentation; therefore, it should not be concluded that it is the same model being considered by the FDA.

Obtaining US FDA approval is not the same as registration with the Thai FDA. There is no publicly available Thai FDA registration information for Dermapen; therefore, you should request the registration number, importer, and model of the device and needles directly from the clinic.

Precautions and things to tell your doctor.

A safety review of microneedling (85 articles) reported common outcomes such as redness, swelling, pain, and dry, peeling skin, which are temporary and can last up to 7 days post-procedure. Permanent and more serious outcomes include post-inflammatory hyperpigmentation (PIH), tram-track scarring, and granulomatous reactions. Risk factors include on-site skin infection, dark skin color, and metal allergies.^[2] Therefore, there is no evidence to support the claims of "no side effects" or "no recovery time needed."“

The skin type of many Thai people falls into the Fitzpatrick III–V range (general information, not based on the source read), which falls within the range specified by the FDA (I–V).^[3] However, darker skin tones are more prone to hyperpigmentation.^[2] You should ask your doctor about the needle depth and post-operative care.

Particular caution should be exercised when applying or using the product in conjunction with microneedling (e.g., PRP serums or other substances). This review warns against using it with products that are not approved for intradermal use.^[2] The clinic's page doesn't specify which products are used in conjunction with the Derma Pen. You should ask for clarification.

Before treatment, you should inform your doctor about: any existing acne or skin infection, metal allergies, history of post-inflammatory hyperpigmentation, history of hypertrophic scars or keloids, any medications you are taking, and pregnancy (the last three points were not checked in the sources I read, but are information your doctor will use to assess). The actual contraindications depend on the device manual and your doctor's assessment.

Things to ask before starting.

Manufacturer, model, and Thai FDA registration number of the device and needles (needles must be sterile, single-use, and changed for each user).
The depth of the needle used for one's specific problem, and how many times it will be done and how far apart they should be.
What products are being used in conjunction with the procedure (PRP serum, exosomes, or others), and are those products approved for intradermal use?
Risk factors for post-inflammatory hyperpigmentation depending on skin tone, the duration of redness or peeling, and sun protection after treatment.
We have before-and-after photos of actual patients at the clinic (with consent) and information on who performed the procedure.

FAQ: Frequently Asked Questions about Derma Pen

What is a Derma Pen (Dermapen)?

According to the clinic, it's a pen-shaped microneedling device that uses small needles to stimulate the skin. The doctor can adjust the needle depth. We also need to ask the clinic to specify the manufacturer, model, and FDA registration number of the device.

Is Derma Pen really effective in treating acne scars?

Nine systematically reviewed RCTs concluded that microneedling is effective for acne scars, but various devices were used, not specifically Dermapen, and the authors noted that there is no standard method yet and more extensive research is needed.^[1] The DP4 version of Equipmed has passed the US FDA's 510(k) review with the indication for facial acne scars.^[3]

Does it help with enlarged pores or stretch marks?

The research found no studies using microneedling alone for enlarged pores. Regarding stretch marks, a review of 100 articles concluded that there is no standard method, and using multiple methods in combination is generally better.^[4] Neither of these is included in the readable FDA indications.^[3]

Is there any recovery time needed after the procedure? What are the risks? And is it suitable for people with a tan complexion?

Redness, swelling, tenderness, and dry, peeling skin are common and may last up to 7 days. More serious outcomes such as post-inflammatory hyperpigmentation, tram-track scarring, and granuloma have been reported. Darker skin tones, infections, and metal allergies increase the risk.^[2] The FDA indication for the DP4 variant covers Fitzpatrick I–V skin.^[3] Those with tan or dark skin should have their risk of hyperpigmentation assessed by a doctor and the needle depth adjusted. Therefore, do not believe claims of "no side effects."“

Can it be used with PRP or exosome serums?

The clinic's website does not specify which products it can be used with. Safety reviews warn to be cautious when using it with products not approved for topical application.^[2] You should inquire about the product name, manufacturer, and registration status before agreeing.

Is the clinic's equipment registered with the FDA (Food and Drug Administration) or the Thai FDA?

The US FDA has a 510(k) entry for Equipmed USA's DP4.^[3] However, it was not specified that the clinic's equipment was this model, and US FDA registration is not equivalent to Thai FDA registration. No verifiable Thai FDA registration information was found, so it is advisable to request the registration number from the clinic.

Consult Derma Pen.

Consult about Derma Pen at Fresh Code Clinic.

Have a doctor assess your skin and scars individually. Inquire about device models, compatible products, and precautions via LINE @freshcodeclinic or at Fresh Code Clinic before making a decision.

Add LINE @freshcodeclinic Consult a doctor.

Address: 19 Sukhumvit Soi 5, BTS Nana Exit 1 (Parking available)
telephone: 083-626-4264
Opening hours: Open daily 11:00–20:00

References

Sitohang IBS, Sirait SAP, Suryanegara J. Microneedling in the treatment of atrophic scars: a systematic review of randomised controlled trials. Int Wound J. 2021;18(5):577-585. doi:10.1111/iwj.13559. (A systematic review of 9 RCTs on atrophic scars, covering a variety of microneedling devices, not specifically Dermapen. The authors indicated no conflict of interest and the research was funded by the Indonesian Ministry of Research. The abstract and article pages in Chrome were not evaluated for quality of individual RCT reports.) https://pmc.ncbi.nlm.nih.gov/articles/PMC8450803/
Chu S, Foulad DP, Mesinkovska NA. Safety profile for microneedling: a systematic review. Dermatol Surg. 2021;47(9):1249-1254. (Systematic review of 85 articles. Searched only PubMed in August 2019. Read from abstracts in PubMed. Funding sources/COI were not checked.) https://pubmed.ncbi.nlm.nih.gov/34448760/
US FDA. 510(k) K221070 “DP4 Microneedling device”. Applicant: Equipmed USA, LLC. Decision made December 20, 2022, pursuant to regulation 21 CFR 878.4430 Class II, code QAI. Source document from accessdata.fda.gov. Read the approval letter and indication form in Chrome. Device details in the summary are available only through the WebFetch summary (this is not an approval from the Thai FDA). https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm?ID=K221070
Seirafianpour F, et al. Systematic review of single and combined treatments for different types of striae: a comparison of striae treatments. J Eur Acad Dermatol Venereol. 2021;35(11):2184-2198. (Review of 100 articles on stretch marks, read from abstracts in the University of Aberdeen archives, no funding/COI checks and no results specifically on microneedling) https://abdn.elsevierpure.com/en/publications/systematic-review-of-single-and-combined-treatments-for-different/

Information stating "as specified by the clinic" has not been verified against the documentation for the actual model used by the clinic.

The information on this page is general and not medical advice. Treatment outcomes and suitability vary from person to person. Consult a doctor before making any decisions.