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
Condition: Acne Vulgaris
MeSH terms: Acne Vulgaris
Study type: Interventional

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.
    

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.
    

Intervention name(s): Skinpen Prescision System
Intervention type(s): Device
Intervention description(s): 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.
Intervention model: Single Group Assignment
Intervention 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)
Primary purpose: Treatment