Hair Removal: Intense Pulsed Light Versus Diode Laser

Hair Removal Clinical Trial

Official title:

Hair Removal by Intense Pulsed Light Versus Diode Laser: Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT06179186
• Other study ID #: RTBB
• Status: Not yet recruiting
• Phase: N/A
• Start date: January 2024
• Est. completion date: July 30, 2025

Study information

• Verified date: December 2023
• Source: University of Nove de Julho
• Contact: Renata Taylor
• Phone: +5511930902810
• Email: renatataylor[@]uni9.edu.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The goal of this clinical trial is to compare the effectiveness of two hair removal techniques: Intense Pulsed Light (IPL) and Diode Laser in woman underarm. .

Main Questions:

• Determine the thread count in a 4cm² quadrant in the central axillary region before each session, 4-6 weeks after the last session and at follow-up 30 weeks after the last session;

• Measure the thickness of the hair before each session, 4-6 weeks after the last session and at follow-up 6 months after the last session;

• Compare the level of pain during procedures;

• Evaluate the volunteer's level of satisfaction after the end of the sessions programmed by the study;

• Evaluate quality of life and self-image before and after the end of the sessions programmed by the study;

• Evaluate the maintenance of results 6 months after the last procedure performed.

Researchers will compare IPL and Diode laser to see if hair removal is similar at short and long time course.

The IPL treatment will be applied to one axilla. The 800nm Diode Laser treatment will be applied to the other axilla. Treatment allocation will be randomized for each participant. Participants will undergo monthly sessions for four months, totaling four treatments. Follow-up assessments will occur 30 days and 6 months after the final session.

Description:

This is a randomized controlled trial of hair removal in axilla for women, being intense pulsed light compared to diode laser.

The session frequency will be once a month for 4 months, totaling 4 treatments. There will be a follow-up at 30 days and 6 months after the end of the treatment.

After the evaluations and photographs, the armpits will be cleaned with 0.5% alcoholic chlorhexidine and will be shaved with a disposable razor blade. Neutral water-based gel will be applied to the region to receive the treatment. Patients will be instructed not to perform any trichotomy procedures in the region during the research period.

The treatment technique will be punctual where the applicator will be kept in full contact with the skin at 90° and moved to the next point after deposition of energy over the entire treatment area until the defined energy is delivered. The applicator tip will be cooled as much as the equipment allows.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 62
• Est. completion date: July 30, 2025
• Est. primary completion date: November 30, 2024
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Female patients,

• aged 18 and older,

• with a complaint of hair in the axillary region,

• Fitzpatrick skin phototype I to IV,

• presenting dark hair

Exclusion Criteria:

• Patients who have used medications that alter hair production,

• Patients who have used medications that are photosensitizing,

• Patients who have used isotretinoin or vitamin A-synthesized acids, antibiotics such as tetracycline,

• Patients using anticoagulant

• Patients with vitiligo or epilepsy,

• Pregnant or lactating individuals,

• those with active herpes,

• Patient with history of tumors,

• Patient with axillary scarring (hyper or hypotrophic),

• Patient who have used another method of hair removal involving complete hair removal by pulling with a minimum period of 30 days from the date of the initial assessment, or have used another laser hair removal method in the treatment area,

• Immunocompromised patients,

• Patients with sun-sensitive skin with inflammation,

• Individuals with psoriasis,

• Patients with tattoos on the application site,

• Patients who have undergone ovary removal or have reached menopause

Related Conditions & MeSH terms

• Hair Removal

Intervention

Device:
• Intense Pulsed Light
The axilla will be treated with intense pulsed light, being right or left, depending upon randomization.
• Diode Laser
The axilla will be treated with diode laser, being right or left, depending upon randomization.

Locations

Country	Name	City	State
Brazil	Universidade Nove de Julho	São Paulo	SP

Sponsors (1)

Lead Sponsor	Collaborator
University of Nove de Julho

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Adverse events	Adverse effects noted during and after treatments will be recorded	before each session (S0,Month1, Month2, Month3), 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
Primary	Hair count	The counting of the hairs will be performed by observing the visible hairs in the treatment area photographs of the volunteers. In this way, a percentage comparison will be made in relation to the initial number of hairs. The hair count will be conducted in a 4cm² quadrant in the central axillary region.	before each session (S0,Month1, Month2, Month3), 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
Primary	Global Aesthetic Improvement Scale (GAIS)	The photographs will be evaluated by two independent and blind evaluators, making a comparison between the photos before the procedure (S0) and the final effect of the short-term (S4) and long-term (S5) treatment. The evaluations will be classified according to the percentage of change: no results 0% reduction, bad reduction 0% to 25%, average 25% to 50%, good 50% to 75% and excellent 75%-100%.	4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
Secondary	Hair Thickness	Images of the demarcated region will be obtained using a dermatoscope (5 images per region per assessment). The hair thickness will be measured using the Image J software (NIH).	before each session (S0,Month1, Month2, Month3), 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
Secondary	Pain Score (Visual Analogue Scale)	Immediately after the end of the procedure in each armpit, the patient will respond using the visual analogue scale (VAS) to the sensation of pain perceived during the procedure.; It consists of a straight line, 10 centimeters long, where one end represents the total absence of pain and the other end represents the most intense pain possible. The person experiencing the pain is asked to mark a point on the line that represents the intensity of the pain they are experiencing. The marked point can be measured in centimeters from the end that represents the absence of pain.	before each session (S0,Month1, Month2, Month3), 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
Secondary	Quality of Live	The WHOQOL-bref quality of life questionnaire consists of 26 questions, with responses following a Likert scale (from 1 to 5, with higher scores indicating better quality of life) his questionnaire includes 2 questions that assess overall quality of life, while the remaining questions make up 4 domains (physical, psychological, social relationships, and environment).	before first session (S0), and at follow-up 24 weeks after the last session (Month 10).
Secondary	Satisfaction level Score	The patient's satisfaction level with the treatment will be assessed through a questionnaire containing five multiple-choice questions. These questions will address the degree of discomfort experienced during the sessions, how many sessions this discomfort persisted, the satisfaction level regarding the achieved results, the perceived percentage improvement in the concern, and, finally, how likely the patient would recommend the undergone treatment to someone with a similar concern. Each response receive 1 up to 5 points, and the total Score varies from 4 to 20, being the highest as the highest the satisfaction.	At follow-up 24 weeks after the last session (Month 10).
Secondary	Self - Esteem Scale	The Self - Esteem Rosenberg Scale consists of 10 statements related to self-evaluation and self-acceptance. Respondents must indicate their level of agreement or disagreement with each statement on a response scale that typically ranges from "strongly disagree" to "strongly agree." The statements are mostly positive and are used to assess the extent to which a person feels positive or negative about themselves.	before first session (S0) and at follow-up 24 weeks after the last session (Month 10).