TerminatedNot Applicable

Hair Removal: Intense Pulsed Light Versus Diode Laser

Stopped: The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.

Brazil48 participantsStarted 2023-11-30

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Hair count

Timeframe: 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)

Timeframe: 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).

Trial details

NCT IDNCT06179186

SponsorUniversity of Nove de Julho

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-11-30

View on ClinicalTrials.gov More Hair Removal trials