Hair Removal by Intense Pulsed Light Versus Diode Laser: Randomized Controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 入组人数
- 48
- 试验地点
- 3
- 主要终点
- Hair count
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Female patients,
- •aged 18 and older,
- •with a complaint of hair in the axillary region,
- •Fitzpatrick skin phototype I to IV,
- •presenting dark hair
排除标准
- •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
结局指标
主要结局
Hair count
时间窗: 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)
时间窗: 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%.
次要结局
- 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).)
研究者
Christiane Pavani
Clinical Professor
University of Nove de Julho