Clinical trial NCT02204436: Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Official title: Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Healthy
Keywords: hyperpigmentation
depigmenting treatment
hand
Lead sponsor: Derming SRL
Sponsor class: OTHER
First posted: 2014-07-30
Enrollment: 22
Sex: FEMALE
Minimum age (years): 45
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 emulsion, with clarifying-antioxidant activity combined with an activator gel, with hydration and keratolytic activity.

Female healthy volunteers aged 45-65 years old, presenting senile lentigo on the hands, were included in the study.

It was also aim of this study to evaluate treatment efficacy and cosmetic acceptability by the volunteers and tolerance both by investigator and volunteers.

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)
* Photographic recovery
* Skin spots image analysis
* Skin colour evaluation
* Spectrophotometry (skin brightness)
* Optical colorimetry (spots colour)

At the end of the study (T8), each volunteer filled a questionnaire regarding:

* the efficacy of the study product (skin brightness and hydration, spots dimensions and colour intensity - score: very marked; marked; medium; light; absent)
* the cosmetic acceptability of the study product: colour and perfume before and after application, consistency, spreadability, absorption, effect on the skin, greasiness and presence of product residues (score: negative; medium; good; excellent) the product tolerance (score: bad; poor; medium; good; excellent).

At the end of the study the investigator assessed the treatment tolerance considering the possible appearance of related adverse events as bad, poor, medium, good, excellent.

Eligibility criteria: Inclusion Criteria:

* 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 Criteria:

* 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

Primary outcomes:
measure: Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)
timeFrame: after 2, 4 and 8-week-treatment
Secondary outcomes:
measure: Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)
timeFrame: after 2, 4 and 8-week-treatment
measure: Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)
timeFrame: after 2, 4 and 8 week-treatment
Other outcomes:
Locations:
city: Monza
country: Italy
facility: DermIng SRL
Study officials:
affiliation: Derming SRL
name: Adele Sparavigna, Doctor
role: PRINCIPAL_INVESTIGATOR
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