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

1. To evaluate the effect of ND-YAG laser hair removal on some skin flora and pathogens: an in vivo study.
2. 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.
3. To assess the relation between this effect and bromohidrosis.

Study Overview

• Status: Recruiting
• Conditions: Changes in Bacterial Count in Axilla After Laser Hair Removal
• Intervention / Treatment: Device: ND;YAG 1064NM LASER

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

• Study Type: Interventional
• Enrollment (Anticipated): 30
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Marwa o Eldeeb; Phone Number: +201200029774; Email: marwa.eldeeb16@alexmed.edu.eg

Study Locations

• Egypt
  • Alexandria, Egypt
    • Recruiting
    • Alexandria University Faculty of Medicine
    • Contact: amira abulfotooh eid, MD; Phone Number: 01006897449; Email: dramiraeid@yahoo.co.uk

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 40 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ND;YAG 1064 NM LASER; monthly sessions of laser hair removal	Device: ND;YAG 1064NM LASER; laser hair removal sessions

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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.	using a questionnaire that is categorized into better , worse or unchanged sweat odour.	4 month

Collaborators and Investigators

• Sponsor: Alexandria University

Study record dates

Study Major Dates

• Study Start (Actual): January 14, 2021
• Primary Completion (Anticipated): January 1, 2022
• Study Completion (Anticipated): January 1, 2022

Study Registration Dates

• First Submitted: July 23, 2021
• First Submitted That Met QC Criteria: August 28, 2021
• First Posted (Actual): September 5, 2021

Study Record Updates

• Last Update Posted (Actual): September 5, 2021
• Last Update Submitted That Met QC Criteria: August 28, 2021
• Last Verified: August 1, 2021

More Information

Terms related to this study

• Other Study ID Numbers: 0106624

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No