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The study was terminated early after interim analysis of 48 participants, which showed significant group differences with 80% power, making further enrollment unnecessary.
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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:
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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intense Pulsed Light | Experimental | The hair from axilla of one side of the body will be removed with 4 sessions of Intense Pulsed Light |
|
| Diode laser | Experimental | The hair from axilla of one side of the body will be removed with 4 sessions of Diode Laser |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intense Pulsed Light | Device | The axilla will be treated with intense pulsed light, being right or left, depending upon randomization. |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
| Measure | Description | Time Frame |
|---|---|---|
| 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). |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Christiane Pavani, PhD | University of Nove de Julho | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Universidade Nove de Julho | São Paulo | São Paulo | 01.504-001 | Brazil | ||
| Ambulatório Universidade Nove de Julho |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42249955 | Derived | 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. |
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| ID | Term |
|---|---|
| D062325 | Intense Pulsed Light Therapy |
| D011897 | Random Allocation |
| D054023 | Lasers, Semiconductor |
| ID | Term |
|---|---|
| D010789 | Phototherapy |
| D013812 | Therapeutics |
| D015340 | Epidemiologic Research Design |
| D004812 | Epidemiologic Methods |
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Participants are assigned two groups in parallel for the duration of the study
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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.
|
| Diode Laser | Device | The axilla will be treated with diode laser, being right or left, depending upon randomization. |
|
|
| 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). |
| 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). |
| 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). |
| 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). |
| São Paulo |
| São Paulo |
| Brazil |
| D008919 |
| Investigative Techniques |
| D012107 | Research Design |
| D008722 | Methods |
| D017531 | Health Care Evaluation Mechanisms |
| D011787 | Quality of Health Care |
| D017530 | Health Care Quality, Access, and Evaluation |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |