CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS IN HEALTHY WOMEN PARTICIPANTS - STUDY UNDER DERMATOLOGICAL CONTROL
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 44
- 试验地点
- 1
- 主要终点
- Change of the pigmentation intensity of solar lentigo
研究概览
简要总结
To assess the efficacy of the Epilady investigational device, used with and without a topical depigmenting formula, in reducing the appearance of lentigo spots on the hands and forearms of healthy female participants over an 84-day period
详细描述
Rational The investigational product in this clinical investigation, the Epilady laser-based device, applies the principle of selective photothermolysis to target melanin within pigmented lesions. It uses diode laser technology at either 660 nm or 808 nm, selected according to the participant's skin phototype, and is equipped with a camera-guided targeting system and integrated safety sensors for precise and controlled energy delivery. The device has been classified as a Class IIb medical device in the EU, intended for the permanent reduction of pigmentation such as lentigines.
Design:
This is a prospective, open-label, randomized, intra-individual controlled clinical investigation conducted in healthy female participants aged 35 to 70 years. The clinical investigation is designed to evaluate the efficacy and safety of the Epilady prototype laser medical device, used alone or in combination with a cosmetic depigmenting formula, in reducing the pigmentation of lentigo spots on the hands and lower forearms.
Following inclusion, the left and right hands (or forearms) of each participant will be randomized:
- One side will receive weekly laser treatments with the device alone, while
- The contralateral side will receive weekly laser treatments with the device followed by twice-daily application of the cosmetic formula starting 24 hours after each laser session and continuing for the remainder of the 84-day period.
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
- Single (Investigator)
入排标准
- 年龄范围
- 35 Years 至 70 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •Healthy female participants aged between 35 and 70 years old at the time of inclusion.
- •All Fitzpatrick skin phototypes (I to VI) are eligible; groups I-II and V-VI should include at least one participant per group.
- •Presence of at least two solar lentigo (dark spots) on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator.
- •Participant has read, understood, and accepted the constraints of the clinical investigation.
- •Participant has provided written informed consent to participate in the clinical investigation.
- •Participant is able to understand the language used in the investigational site and comprehend the information provided.
- •Participants are cooperative and compliant, aware of the clinical investigation requirements and willing to adhere to the full duration of participation and follow-up visits, in line with the CIP requirements.
- •Women of childbearing potential must commit to using an effective contraceptive method throughout the clinical investigation period and for at least three months prior to the inclusion visit, with no changes during that time.
排除标准
- •• Participants with dry or sensitive skin, as assessed by the investigator.
- •Participants who have used cosmetic products with exfoliating or astringent claims on the hands within 4 weeks prior to the baseline visit.
- •Participants who have used any home-use or professional low-level laser therapy (LLLT) or have participated in clinical studies involving LLLT within the 6 months preceding the baseline visit
- •History of light-induced seizures or chronic migraine disorders.
- •History of photosensitivity or photoallergic reactions.
- •Presence of underlying dermatological conditions on the hands/forearms that, in the opinion of the investigator, could interfere with the clinical investigation assessments.
- •A family history of melanoma in first- or second-degree relatives (parents or grandparents).
- •Presence of excessive moles, non-lentigo pigmented lesions, tattoos, scars, or irritated skin in the test area that could affect the validity of the investigation.
- •History of surgical procedures involving the areas designated for treatment.
- •Participants who have been exposed to or plan to be exposed to sunbathing or artificial UV sources (e.g., mountain sports, phototherapy, tanning salons) within 1 month before the clinical investigation start or during the clinical investigation period.
- •Use of suntan or self-tanning products within the 2 weeks preceding the baseline visit.
- •Change in cosmetic habits (e.g., moisturizers, skincare, shower gels) during the 2 weeks prior to baseline.
- •Use of any medications, topical treatments, skincare products, or aesthetic procedures listed in the CIP without observing the required wash-out periods, or unwillingness/inability to comply with those restrictions during the clinical investigation.
- •Participant who cannot be contacted by telephone in case of emergency
- •Participant in an exclusion period or participating in another biomedical research clinical investigation (self-reported)
- •Intellectual/mental inability to follow clinical investigation instructions (if suspected) or incapacitation.
- •Participants working for the contract research organization (CIDP) in charge of this clinical investigation.
结局指标
主要结局
Change of the pigmentation intensity of solar lentigo
时间窗: baseline to 3 months
The investigator will perform a standardized clinical evaluation of the targeted lentigo lesions, grading pigmentation intensity using a standardized Color Chart (2021-EV-FR-ICE-Color Chart Procedure, see figure 2) to assess the darkness of each lentigo lesion compared to the surrounding skin.
Global tolerance
时间窗: 1 month to 3 months
The investigator will assign an overall tolerance score for the treatment area at each visit using the following scale 1: very good ; 2: good; 3: Moderate; 4: Bad
次要结局
- Lentigines Global Improvement Scale (LGIS)(baseline to 3 months)
- Self assessment questionnaire(3 months)