CLINICAL INVESTIGATION TO EVALUATE THE EFFICACY AND SAFETY OF EPILADY PROTOTYPE DEVICE FOLLOWED BY APPLICATION OF A TOPICAL FORMULA ON DEPIGMENTATION OF LENTIGO SPOTS

NCT07239726 | Not Yet Recruiting

• 1 other identifier: EV2409-0042 / ID 24-14993
• Study Type: interventional
• Target: 44
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Solar Lentigo

Keywords

solar lentigo,; Laser treatment

Outcome Measures

Primary Outcomes (2)

• Change of the pigmentation intensity of solar lentigo

  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.

  baseline to 3 months

• Global tolerance

  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

  1 month to 3 months

Secondary Outcomes (2)

• Lentigines Global Improvement Scale (LGIS)

  baseline to 3 months

• Self assessment questionnaire

  3 months

Study Arms (2)

LASER

EXPERIMENTAL

Healthy participants aged between 35 and 70 years old with presence of at least two solar lentigo on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator

Other: LASER

LASER AND ACTIVE FLORMULA

ACTIVE COMPARATOR

Healthy participants aged between 35 and 70 years old with presence of at least two solar lentigo on each hand or forearm, with each spot measuring less than 100 mm x 100 mm as assessed by the investigator

Combination Product: LASER AND ACTIVE FORMULA

Interventions

LASER OTHER

Application of laser once a weeks by dermatologist on spot and application of sunscreen twice a day ( morning and midday) for 3 months

LASER

LASER AND ACTIVE FORMULA COMBINATION_PRODUCT

application of laser once a week by dermatologist, active formula twice a day ( morning and evening) and sunscreen formula twice a day (morning and midday) for 3 months

LASER AND ACTIVE FLORMULA

Eligibility Criteria

• Age: 35 Years - 70 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• Intellectual/mental inability to follow clinical investigation instructions (if suspected) or incapacitation.

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

CIDP Ltée

Phoenix, Mauritius

Location

MeSH Terms

Interventions

Lasers

Intervention Hierarchy (Ancestors)

Optical Devices; Equipment and Supplies; Radiation Equipment and Supplies

Central Study Contacts

Gitanjali PETKAR

CONTACT

(+230) 4012600; g.petkar@cidp-cro.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2025
• First Posted: November 20, 2025
• Study Start: January 7, 2026
• Primary Completion (Estimated): May 8, 2026
• Study Completion (Estimated): May 8, 2026
• Last Updated: November 20, 2025

Record last verified: 2025-11

Locations

MA (1)