Clinical Trials Logo
  1. Home
  2. Acne Vulgaris
  3. NCT05071274

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

Acne Vulgaris Clinical Trial

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

Clinical 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.

Clinical Trial 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

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05071274
Study type Interventional
Source Crown Laboratories, Inc.
Contact
Status Completed
Phase N/A
Start date March 15, 2021
Completion date March 18, 2022
View Details
See also
  Status Clinical Trial Phase
Completed NCT04321070 - Bio-equivalence Study With Clinical Endpoints in the Treatment of Acne Vulgaris Phase 1
Recruiting NCT05755256 - The Impact of Probiotics on Skin Hydration in Youth With Mild Acne Phase 2
Completed NCT05131373 - Safety, Tolerability, and Immunogenicity of ORI-A-ce001 for the Treatment of Acne Vulgaris Phase 1
Completed NCT01445301 - Study STF115287, a Clinical Confirmation Study of GSK2585823 in the Treatment of Acne Vulgaris in Japanese Subjects Phase 3
Completed NCT03303170 - Non-Significant Risk Study of Sebacia Microparticles in the Treatment of Facial Acne Vulgaris N/A
Completed NCT04698239 - Clinical Evaluation of the Safety and Benefits of the Milesman 445 nm Blue Laser on Inflammatory Acne Lesions. N/A
Completed NCT02886715 - A Study Comparing Tazarotene Cream 0.1% to TAZORAC® (Tazarotene) Cream 0.1% and Both to a Placebo Control in the Treatment of Acne Vulgaris Phase 3
Terminated NCT02924428 - Venus Versa Diamondpolar Applicator Treatment Followed by AC Dual Applicator Treatment for Facial Acne Vulgaris N/A
Not yet recruiting NCT02491060 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Not yet recruiting NCT02525822 - Study to Compare the Safety and Efficacy of IDP-123 Lotion to Tazorac Cream in the Treatment of Acne Vulgaris Phase 2
Completed NCT02709902 - Study Comparing Adapalene/BP Gel to EPIDUO® FORTE and Both to a Placebo Control in Treatment of Acne Vulgaris Phase 1
Not yet recruiting NCT02535871 - A Study Comparing the Efficacy and Safety of IDP-121 and IDP-121 Vehicle Lotion in the Treatment of Acne Vulgaris Phase 3
Completed NCT02250430 - A Phase 1 Study Assessing Local Cutaneous Effects of SB204 Phase 1
Completed NCT02913001 - The Effect of a Low Glycemic Load Diet on Hormonal Markers Associated With Acne N/A
Completed NCT01694810 - Cutaneous Tolerability and Safety of NVN1000 Topical Gel in Healthy Volunteers Phase 1
Completed NCT01769664 - A Study Comparing Clindamycin 1%/Benzoyl Peroxide 5% Topical Gel to Duac® Topical Gel in the Treatment of Acne Vulgaris Phase 1
Completed NCT01727440 - Identifying the Genetic Predictors of Severe Acne Vulgaris and the Outcome of Oral Isotretinoin Treatment N/A
Completed NCT01194375 - A Dose-Ranging Study Evaluating the Safety and Efficacy of IDP-107 in Patients With Acne Vulgaris Phase 2
Completed NCT02524665 - 8 Week Study to Evaluate and Compare the Efficacy and Tolerability of MAXCLARITY II and MURAD To Treat Acne Phase 4
Completed NCT01706250 - U0289-401: Eight Week, Split-face, Study to Determine and Compare the Efficacy and Tolerability of MAXCLARITY™ II to PROACTIV™ Phase 4