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Clinical Study for the Evaluation of the Depigmenting Activity of a Cosmetic Product on Spotted Hand Skin

29 juli 2014 bijgewerkt door: Derming SRL

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.

Studie Overzicht

Toestand

Voltooid

Conditie

Interventie / Behandeling

Gedetailleerde beschrijving

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.

Studietype

Ingrijpend

Inschrijving (Werkelijk)

22

Fase

  • Fase 3

Contacten en locaties

In dit gedeelte vindt u de contactgegevens van degenen die het onderzoek uitvoeren en informatie over waar dit onderzoek wordt uitgevoerd.

Studie Locaties

  • Italië
      • Monza, Italië, 20900
        • DermIng SRL

Deelname Criteria

Onderzoekers zoeken naar mensen die aan een bepaalde beschrijving voldoen, de zogenaamde geschiktheidscriteria. Enkele voorbeelden van deze criteria zijn iemands algemene gezondheidstoestand of eerdere behandelingen.

Geschiktheidscriteria

Leeftijden die in aanmerking komen voor studie

45 jaar tot 65 jaar (Volwassen, Oudere volwassene)

Accepteert gezonde vrijwilligers

Ja

Geslachten die in aanmerking komen voor studie

Vrouw

Beschrijving

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

Studie plan

Dit gedeelte bevat details van het studieplan, inclusief hoe de studie is opgezet en wat de studie meet.

Hoe is de studie opgezet?

Ontwerpdetails

  • Primair doel: Behandeling
  • Toewijzing: NVT
  • Interventioneel model: Opdracht voor een enkele groep
  • Masker: Geen (open label)

Wapens en interventies

Deelnemersgroep / Arm
Interventie / Behandeling
Ander: Emulsion and gel
A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.
Ander: Emulsion and gel
A fixed similar quantity of both emulsion and gel were applied consequentially on the hand twice a day, in the morning and in the evening (preferentially always at the same hour), with a mild massage, until complete absorption, for 8 weeks.

Wat meet het onderzoek?

Primaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)
Tijdsspanne: after 2, 4 and 8-week-treatment
Skin spots area was measured on the pre-selected images performed with or without Wood's lamp. The measure of skin spots area was performed by means of an image analysis software, with a function called "magic wand". Based on the colour similarities or on the difference of intensity ranges between the selected pixels (with a specified tolerance interval) the magic wand automatically traced the outline of the spot and measured the selected area (pixel2).
after 2, 4 and 8-week-treatment

Secundaire uitkomstmaten

Uitkomstmaat
Maatregel Beschrijving
Tijdsspanne
Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)
Tijdsspanne: after 2, 4 and 8-week-treatment
Skin brightness was measured by a visible-UV-IR (λ from 300 to 900 nm) spectrophotometer which uses a tungsten halogen lamp and a deuterium lamp in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. Lamps were switched on 30 minutes before instrument use in order to join a stable emission. Measurement angle was 90° (position of the probe on the skin) and measured area was 2 mm2; used wavelength range was 380-780 nm corresponds to the visible light spectrum.
after 2, 4 and 8-week-treatment
Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)
Tijdsspanne: after 2, 4 and 8 week-treatment
Measurement of spots colour were performed by a tri-stimulus colorimeter equipped with three special filters to obtain R,G,B values in accordance with CIE (Commission Internationale de l'Eclarage), the main international organisation concerned with colour and colour measurement. CIE L*a*b* system (CIELAB) is the most complete colour-space specified by the CIE (1976). It describes all the colours visible to the human eye; the three coordinates of L*a*b* represent the lightness of the colour (L* = 0 yields black and L* = 100 indicates diffuse white; specular white may be higher), its position between red/magenta and green (a*, negative values indicate green while positive values indicate magenta) and its position between yellow and blue (b*, negative values indicate blue and positive values indicate yellow).
after 2, 4 and 8 week-treatment

Medewerkers en onderzoekers

Hier vindt u mensen en organisaties die betrokken zijn bij dit onderzoek.

Sponsor

Derming SRL

Publicaties en nuttige links

De persoon die verantwoordelijk is voor het invoeren van informatie over het onderzoek stelt deze publicaties vrijwillig ter beschikking. Dit kan gaan over alles wat met het onderzoek te maken heeft.

Algemene publicaties

Nuttige links

Studie record data

Deze datums volgen de voortgang van het onderzoeksdossier en de samenvatting van de ingediende resultaten bij ClinicalTrials.gov. Studieverslagen en gerapporteerde resultaten worden beoordeeld door de National Library of Medicine (NLM) om er zeker van te zijn dat ze voldoen aan specifieke kwaliteitscontrolenormen voordat ze op de openbare website worden geplaatst.

Bestudeer belangrijke data

Studie start

1 november 2013

Primaire voltooiing (Werkelijk)

1 januari 2014

Studie voltooiing (Werkelijk)

1 januari 2014

Studieregistratiedata

Eerst ingediend

18 juli 2014

Eerst ingediend dat voldeed aan de QC-criteria

29 juli 2014

Eerst geplaatst (Schatting)

30 juli 2014

Updates van studierecords

Laatste update geplaatst (Schatting)

30 juli 2014

Laatste update ingediend die voldeed aan QC-criteria

29 juli 2014

Laatst geverifieerd

1 maart 2014

Meer informatie

Termen gerelateerd aan deze studie

Trefwoorden

Andere studie-ID-nummers

  • E3013

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