Hair RemovalNCT06179186
Hair Removal: Intense Pulsed Light Versus Diode Laser
A study testing Intense Pulsed Light and Diode Laser in people with Hair Removal, run by University of Nove de Julho at 2 sites in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Hair Removal
- What is being tested?
- Intense Pulsed Light and Diode Laser
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 2 sitesBrazil
- Study dates
- 30 Nov 2023to 30 Nov 2024
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients,
- aged 18 and older,
- with a complaint of hair in the axillary region,
- Fitzpatrick skin phototype I to IV,
- presenting dark hair
Who cannot join
- 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,
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- 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
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
Universidade Nove de Julho
São Paulo, São Paulo, 01.504-001
Ambulatório Universidade Nove de Julho
São Paulo, São Paulo
About this study
Official title: Hair Removal by Intense Pulsed Light Versus Diode Laser: Randomized Controlled Clinical Trial
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:
Read more
- 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.
Read the detailed 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.
- Conditions
- Hair Removal
- Being tested
- Intense Pulsed Light, Diode Laser
- Keywords
- hair removal, diode laser, photoepilation, intense pulsed light, epilation, Depilation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intense Pulsed LightDevice
Also called Randomized
The axilla will be treated with intense pulsed light, being right or left, depending upon randomization.
Diode LaserDevice
Also called Randomized
The axilla will be treated with diode laser, being right or left, depending upon randomization.
| Study group | Role | What they receive |
|---|---|---|
| Intense Pulsed Light | Experimental | The hair from axilla of one side of the body will be removed with 4 sessions of Intense Pulsed Light Receives: 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 Receives: Device: Intense Pulsed Light; Device: Diode Laser |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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%.
Measured: 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
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).
Measured: 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)
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.
Measured: 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
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).
Measured: before first session (S0), and at follow-up 24 weeks after the last session (Month 10).
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.
Measured: At follow-up 24 weeks after the last session (Month 10).
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.
Measured: before first session (S0) and at follow-up 24 weeks after the last session (Month 10).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Dec 2023
- Study start30 Nov 2023
- Primary completion30 Nov 2024
- Study completion30 Nov 2024
Why it stopped: The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hair RemovalStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are assigned two groups in parallel for the duration of the study
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nove de Julho
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christiane Pavani, University of Nove de Julho
- Investigators
- Christiane Pavani, PhD, Study director, University of Nove de Julho
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06179186
- Sponsor's protocol ID
- RTBB
- Status last verified
- Aug 2025
- First submitted
- 11 Dec 2023
- Last updated
- 27 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Barros RTB, Stella OHAS, Galache TR, Khachikian LC, Liebano RE, Pavani C. Efficacy and safety of intense pulsed light compared to diode Laser for hair removal: a randomized controlled trial. Lasers Med Sci. 2026 Jun 6;41(1):108. doi: 10.1007/s10103-026-04904-6.
PubMed 42249955
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Hair Removal by Intense Pulsed Light Versus Diode Laser: Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06179186
- Acronym / sponsor ID
- RTBB
- Conditions
- Hair Removal
- Keywords
- hair removal, diode laser, photoepilation, intense pulsed light, epilation, Depilation
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of Nove de JulhoUniversity, hospital or other
- Study start
- 30 Nov 2023 (actual)
- Primary completion
- 30 Nov 2024 (actual)
- Study completion
- 30 Nov 2024 (actual)
- First posted
- 21 Dec 2023 (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.
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.
Detailed 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- Participants are assigned two groups in parallel for the duration of the study
| Arm | Type | Receives |
|---|---|---|
| Intense Pulsed Light | Experimental | Device: Intense Pulsed Light, Device: Diode LaserThe hair from axilla of one side of the body will be removed with 4 sessions of Intense Pulsed Light |
| Diode laser | Experimental | Device: Intense Pulsed Light, Device: Diode LaserThe hair from axilla of one side of the body will be removed with 4 sessions of Diode Laser |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Female patients,
- aged 18 and older,
- with a complaint of hair in the axillary region,
- Fitzpatrick skin phototype I to IV,
- presenting dark hair
Key exclusion criteria (15 listed)
- 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,
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 |
|---|---|---|
| Intense Pulsed LightAlso: RandomizedThe axilla will be treated with intense pulsed light, being right or left, depending upon randomization. | Device | Diode laser, Intense Pulsed Light |
| Diode LaserAlso: RandomizedThe axilla will be treated with diode laser, being right or left, depending upon randomization. | Device | Diode laser, Intense Pulsed Light |
Primary outcome
Hair count
Time frame: 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).
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.
Global Aesthetic Improvement Scale (GAIS)
Time frame: 4-6 weeks after the last session (Month4) and at follow-up 24 weeks after the last session (Month 10).
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%.
5 secondary outcomes
Hair Thickness
Time frame: 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)
Time frame: 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
Time frame: before first session (S0), and at follow-up 24 weeks after the last session (Month 10).
Satisfaction level Score
Time frame: At follow-up 24 weeks after the last session (Month 10).
Self - Esteem Scale
Time frame: before first session (S0) and at follow-up 24 weeks after the last session (Month 10).
Results and safety
The study was stopped early (reason given: The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Aug 2025.
- Derived from this study: PubMed 42249955Barros RTB, Stella OHAS, Galache TR, Khachikian LC, Liebano RE, Pavani C. Efficacy and safety of intense pulsed light compared to diode Laser for hair removal: a randomized controlled trial. Lasers Med Sci. 2026 Jun 6;41(1):108. doi: 10.1007/s10103-026-04904-6.
- Individual participant dataSharing planned: No
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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.
Christiane Pavani, PhD study director
University of Nove de Julho
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intense Pulsed Light and Diode Laser in people with Hair Removal, run by University of Nove de Julho at 2 sites in Brazil.
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 5 inclusion and 15 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: stopped early, as of the sponsor's last update on 27 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
The study was stopped early (reason given: The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Hair count (time frame: 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).). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06179186, which also lists 1 linked publication.
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 27 Aug 2025.