Ignite Creation Date:
2024-05-06 @ 4:44 PM
Last Modification Date:
2024-10-26 @ 2:15 PM
Study NCT ID:
NCT05071274
Status:
COMPLETED
Last Update Posted:
2022-03-28
First Post:
2021-09-22
Brief 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
Sponsor:
Crown Laboratories Inc
Organization:
Crown Laboratories Inc
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2022-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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 Sponsors 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 Sponsors 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
isebaceous 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 isotretinoins 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
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
isebaceous 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 isotretinoins 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
True
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?:
None