Changes in Bacterial Count in Axilla After Laser Hair RemovalNCT05034237
The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study
A study testing ND;YAG 1064NM LASER in people with Changes in Bacterial Count in Axilla After Laser Hair Removal, run by Alexandria University at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 20 to 40 years, women only
- Conditions the study is for
- Changes in Bacterial Count in Axilla After Laser Hair Removal
- What is being tested?
- ND;YAG 1064NM LASER
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteEgypt
- Study dates
- 14 Jan 2021to Jan 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- No previous laser hair removal sessions involving axilla. Fitzpatrick skin type III-VI.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
Egypt1 site, 1 recruiting
- Recruiting
Alexandria University Faculty of Medicine
Alexandria
amira abulfotooh eid, MD, 01006897449, dramiraeid@yahoo.co.uk
About this study
- 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.
Read the 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).
- Swabs will be collected immediately and after each session
- Being tested
- ND;YAG 1064NM LASER
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ND;YAG 1064NM LASERDevice
laser hair removal sessions
| Study group | Role | What they receive |
|---|---|---|
| ND;YAG 1064 NM LASER | Experimental | monthly sessions of laser hair removal Receives: Device: ND;YAG 1064NM LASER |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 4 month
Secondary outcomes (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
counting bacterial colonies immediately before and immediately after each laser session
Measured: 4 month
To assess the relation between this effect and bromohidrosis.
using a questionnaire that is categorized into better , worse or unchanged sweat odour.
Measured: 4 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Sep 2021
- Study start14 Jan 2021
- Primary completionJan 2022 (estimated)
- Study completionJan 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Changes in Bacterial Count in Axilla After Laser Hair RemovalStudies of the same condition, open and under way.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, marwa eldeeb, Alexandria University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05034237
- Sponsor's protocol ID
- 0106624
- Status last verified
- Aug 2021
- First submitted
- 23 Jul 2021
- Last updated
- 5 Sep 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Sep 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Long-pulsed 1064 nm nd: Yag Laser-assisted Hair Removal on Some Skin Flora and Pathogens: an in Vivo Study
- ClinicalTrials.gov ID
- NCT05034237
- Acronym / sponsor ID
- 0106624
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 30 participants (estimated)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 14 Jan 2021 (actual)
- Primary completion
- Jan 2022 (estimated)
- Study completion
- Jan 2022 (estimated)
- First posted
- 5 Sep 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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).
- Swabs will be collected immediately and after each session
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| ND;YAG 1064 NM LASER | Experimental | Device: ND;YAG 1064NM LASERmonthly sessions of laser hair removal |
Who may qualify
- Ages
- 20 to 40 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- No previous laser hair removal sessions involving axilla. Fitzpatrick skin type III-VI.
Key exclusion criteria (4 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ND;YAG 1064NM LASERlaser hair removal sessions | Device | ND;YAG 1064 NM LASER |
Primary outcome
to compare changes in bacterial count and composition of axillary flora after laser hair removal
Time frame: 4 month
counting bacterial colonies (aerobic,anaerobic,lipophyllic and staphylococcal) using colony counter
2 secondary outcomes
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
Time frame: 4 month
To assess the relation between this effect and bromohidrosis.
Time frame: 4 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Sep 2021.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing ND;YAG 1064NM LASER in people with Changes in Bacterial Count in Axilla After Laser Hair Removal, run by Alexandria University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Sep 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Marwa o Eldeeb (+201200029774, marwa.eldeeb16@alexmed.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
to compare changes in bacterial count and composition of axillary flora after laser hair removal (time frame: 4 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Sep 2021.