Ignite Creation Date:
2024-10-26 @ 3:42 PM
Last Modification Date:
2024-10-26 @ 3:42 PM
Study NCT ID:
NCT06636799
Status:
COMPLETED
Last Update Posted:
None
First Post:
2024-09-20
Brief Title:
MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM
Sponsor:
None
Organization:
None
Study Overview
Official Title:
EFFECTS OF MICRONEEDLING ON CLINICAL PARAMETERS OF STRIAE ALBA AND MORPHOLOGICAL PARAMETERS OF THE FEMALE TEGUMENTARY SYSTEM A RANDOMIZED CLINICAL TRIAL
Status:
COMPLETED
Status Verified Date:
2024-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Stretch marks are dermal scars of multifactorial etiology for which several treatments have been proposed Among these is microneedling MN a technique that stimulates collagen production However the effects of MA alone and in combination with active agents on the length and area of stretch marks and the thickness of the integumentary system are not well understood as the literature is scarce Therefore the objectives of this study were To assess the effects of MA alone and in combination with active agents growth factors hyaluronic acid and Hydroxyprolisilane CN on clinical parameters area and length of stretch marks and morphological parameters dermal and hypodermal thickness of the female integumentary system The sample was randomized into a control group G1 that did not receive treatment G2 that received MN alone and G3 that received MN combined with active agents Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval Groups were evaluated at the beginning and 4 months after the start of the protocol Evaluation of the area and length of stretch marks was performed through photography dermal and hypodermal thickness was assessed via ultrasonography and satisfaction levels were measured using the Likert scale
Detailed Description:
This study was a randomized clinical trial in blocks with a 11 allocation stratified by weight The study was duly adapted to resolution 46612 of the National Health Council on research involving human beings and to the Declaration of Helsinki The evaluations and treatment protocols were carried out at the Physiotherapy Clinic of a Private Higher Education Institution The sample was characterized by convenience and healthy women who met the inclusion criteria were recruited mainly via social networks To calculate the sample size the G-Power software version 313 University of Trier Trier Germany was used and the significance level adopted was α 005 and power 1-β 080 No similar studies were found so f 030 was used as the effect size Therefore the minimum number of participants required for the study was estimated at 24 participants Considering possible losses during the protocol 26 participants 10 were recruited Randomization was performed by stratifying by weight The randomization list was kept in opaque and sealed envelopes ensuring that the allocation was hidden and random and that the therapist responsible for applying the microneedling had contact with the randomization only on the day of the protocol application In the present study the sample of 26 participants was divided into three groups Group one G1 control composed of eight people underwent all the evaluations but did not receive the microneedling protocol or actives Group two G2 composed of nine people underwent all the proposed evaluations and the isolated microneedling procedure Group three G3 composed of nine people underwent all the proposed evaluations and the microneedling procedure associated with actives Groups G2 and G3 underwent 3 sessions of the protocol with a 4-week interval Groups were evaluated at the beginning and 4 months after the start of the protocol Evaluation of the area and length of stretch marks was performed through photography dermal and hypodermal thickness was assessed via ultrasonography and satisfaction levels were measured using the Likert scaleThis study adopted the intention-to-treat approach Therefore participants who did not attend the scheduled sessions were rescheduled allowing all sessions planned to be carried out When the decision was made to withdraw the data collected up until the end were used for analysis
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None