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

ConditionSolar Lentigo
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age35-70
SponsorCosmetique Active International

About this trial

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

Eligibility criteria

Qualifiers

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.

Disqualifiers

• 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.

Trial design

Treatments tested in this trial

  • LASER
  • LASER AND ACTIVE FORMULA

Treatment groups

44 Participants
are divided into 2 treatment groups