Status:
COMPLETED
Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Lead Sponsor:
Derming SRL
Conditions:
Healthy
Eligibility:
FEMALE
45-65 years
Phase:
PHASE3
Brief Summary
Aim of the study was to evaluate by instrumental measurements the depigmenting activity of a cosmetic treatment for spotted hand skin; in particular it was investigated the synergic activity of an emu...
Detailed Description
The following instrumental evaluations were performed in basal conditions (T0 - before product use), after 4 (T4) and 8 week-treatment (T8): * Image analysis with UV flash (Wood's light) * Photograph...
Eligibility Criteria
Inclusion
- female healthy subjects
- age 45-65 years
- presence of moderate senile lentigo on the back of the hands
- accepting to not receive any drugs/cosmetic/chemical or physical treatment (peeling, intradermal implants etc.) able to change the skin characteristics during the entire duration of the study
- accepting to use the study product according to the instruction received by the investigator
- accepting not to expose to strong UV irradiation (UV session, or sun bathes) during the entire duration of the study
- subject agreeing not to use anti-spots products/treatments during the month preceding the test
- accepting to sign the Informed Consent Form
Exclusion
- pregnancy
- lactation
- sensitivity to the test product or its ingredients
- subjects whose insufficient adhesion to the study protocol is foreseeable
- participation in a similar study actually or during the previous 3 months
- dermatological disease (dermatitis; presence of cutaneous disease on the tested area, as lesions, scars, malformations)
- clinical and significant skin condition on the test area (e.g. active eczema, dermatitis, psoriasis. etc.)
- diabetes
- endocrine disease
- hepatic disorder
- renal disorder
- cardiac disorder
- pulmonary disease
- cancer
- neurological or psychological disease
- inflammatory/immunosuppressive disease
- drug allergy
- systemic corticosteroids
- aspirin or non-steroid anti-inflammatory drugs (FANS)
- anti-histaminic, narcotic, antidepressant, immunosuppressive drugs (with except of contraceptive or hormonal treatment starting from at least 1 year)
- assumption of drugs able to influence the test results in the investigator opinion
Key Trial Info
Start Date :
November 1 2013
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 1 2014
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT02204436
Start Date
November 1 2013
End Date
January 1 2014
Last Update
July 30 2014
Active Locations (1)
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1
DermIng SRL
Monza, Monza, Italy, 20900