Hair Removal: Intense Pulsed Light Versus Diode Laser

NCT06179186 | Terminated

• 1 other identifier: RTBB
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 2

Brief 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.

Conditions

Hair Removal

Keywords

hair removal; diode laser; photoepilation; intense pulsed light; epilation; Depilation

Outcome Measures

Primary Outcomes (2)

• 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).

• 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 Outcomes (5)

• Hair Thickness

  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).

• Pain Score (Visual Analogue Scale)

  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).

• Quality of Live

  before first session (S0), and at follow-up 24 weeks after the last session (Month 10).

• Satisfaction level Score

  At follow-up 24 weeks after the last session (Month 10).

• Self - Esteem Scale

  before first session (S0) and at follow-up 24 weeks after the last session (Month 10).

Other Outcomes (1)

• Adverse events

  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).

Study Arms (2)

Intense Pulsed Light

EXPERIMENTAL

The hair from axilla of one side of the body will be removed with 4 sessions of Intense Pulsed Light

Device: Intense Pulsed Light; Device: Diode Laser

Diode laser

EXPERIMENTAL

The hair from axilla of one side of the body will be removed with 4 sessions of Diode Laser

Device: Intense Pulsed Light; Device: Diode Laser

Interventions

Intense Pulsed Light DEVICE

The axilla will be treated with intense pulsed light, being right or left, depending upon randomization.

Also known as: Randomized

Diode laser; Intense Pulsed Light

Diode Laser DEVICE

The axilla will be treated with diode laser, being right or left, depending upon randomization.

Also known as: Randomized

Diode laser; Intense Pulsed Light

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female patients,
• aged 18 and older,
• with a complaint of hair in the axillary region,
• Fitzpatrick skin phototype I to IV,
• presenting dark hair

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nove de Julho: lead

Study Sites (2)

Universidade Nove de Julho

São Paulo, São Paulo, 01.504-001, Brazil

Location

Ambulatório Universidade Nove de Julho

São Paulo, São Paulo, Brazil

Location

MeSH Terms

Interventions

Intense Pulsed Light Therapy; Random Allocation; Lasers, Semiconductor

Intervention Hierarchy (Ancestors)

Phototherapy; Therapeutics; Epidemiologic Research Design; Epidemiologic Methods; Investigative Techniques; Research Design; Methods; Health Care Evaluation Mechanisms; Quality of Health Care; Health Care Quality, Access, and Evaluation; Public Health; Environment and Public Health; Lasers; Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Study Officials

• Christiane Pavani, PhD

  University of Nove de Julho

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: participants will receive both treatments in right and left axilla, and they won´t know which treatment will be performed at each side. The outcome assessor won´t know which treatment was performed at the axilla.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Clinical Professor

Model Details: Participants are assigned two groups in parallel for the duration of the study

Study Record Dates

• First Submitted: December 11, 2023
• First Posted: December 21, 2023
• Study Start: November 30, 2023
• Primary Completion: November 30, 2024
• Study Completion: November 30, 2024
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

BR (2)