The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted... | NCT05034237

Studies
The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study

NCT05034237

Sponsor

Alexandria University

Status

Unknown status

Last Update Posted

Sep 5, 2021Actual

Enrollment

30Estimated

Phase

Not Applicable

Conditions

Changes in Bacterial Count in Axilla After Laser Hair Removal

Interventions

ND;YAG 1064NM LASER

Countries

Egypt

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Aug 2021

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 14, 2021Actual

Primary Completion Date

Jan 2022Estimated

Completion Date

Jan 2022Estimated

First Submitted Date

Jul 23, 2021

First Submission Date that Met QC Criteria

Aug 28, 2021

First Posted Date

Sep 5, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Aug 28, 2021

Last Update Posted Date

Sep 5, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

To evaluate the effect of ND-YAG laser hair removal on some skin flora and pathogens: an in vivo study.
To determine the immediate and long term effect of ND-YAG laser on total viable bacterial count, some skin flora and pathogens of laser-assisted hair removal in axilla.
To assess the relation between this effect and bromohidrosis.

Detailed Description

This Quasi-experimental interrupted time series study will be conducted on 30 female participants who will be recruited from the Dermatology Outpatient Clinic of the Alexandria Main University Hospital.

Four sessions of laser assisted hair removal at 4 weeks intervals (S1, S2, S3 and S4) using long pulsed ND: YAG (Cynosure Elite+™, Westford, USA). The following parameters will be used according to the nature of hair (1064 nm, 15-18 mm spot size, fluence of 24-35 J/cm2, pulse duration 30-40 ms).

4. Swabs will be collected immediately and after each session

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

30Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
ND;YAG 1064 NM LASER	Experimental	monthly sessions of laser hair removal	Device: ND;YAG 1064NM LASER

Interventions

Name	Type	Description	Arm Group Labels	Other Names
ND;YAG 1064NM LASER	Device	laser hair removal sessions	ND;YAG 1064 NM LASER

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
to compare changes in bacterial count and composition of axillary flora after laser hair removal	counting bacterial colonies (aerobic,anaerobic,lipophyllic and staphylococcal) using colony counter	4 month

Secondary Outcomes

Measure	Description	Time Frame
To determine the immediate and long term effect of ND-YAG laser on total viable bacterial count, some skin flora and pathogens of laser-assisted hair removal in axilla	counting bacterial colonies immediately before and immediately after each laser session	4 month
To assess the relation between this effect and bromohidrosis.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

No previous laser hair removal sessions involving axilla. Fitzpatrick skin type III-VI.

Exclusion Criteria:

Skin diseases such as atopic dermatitis, psoriasis, fungal or herpetic infections.
Systemic diseases such as diabetes or endocrinal dysfunction.
Patients receiving immunosuppressive therapy.
Pregnant or lactating females.

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Marwa o Eldeeb	Contact	+201200029774		marwa.eldeeb16@alexmed.edu.eg

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Alexandria University Faculty of Medicine	Recruiting	Alexandria			Egypt

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided