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

29 juillet 2014 mis à jour par: 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.

Aperçu de l'étude

Statut

Complété

Les conditions

Intervention / Traitement

Description détaillée

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.

Type d'étude

Interventionnel

Inscription (Réel)

22

Phase

  • Phase 3

Contacts et emplacements

Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.

Lieux d'étude

  • Italie
      • Monza, Italie, 20900
        • DermIng SRL

Critères de participation

Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.

Critère d'éligibilité

Âges éligibles pour étudier

45 ans à 65 ans (Adulte, Adulte plus âgé)

Accepte les volontaires sains

Oui

Sexes éligibles pour l'étude

Femelle

La description

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

Plan d'étude

Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.

Comment l'étude est-elle conçue ?

Détails de conception

  • Objectif principal: Traitement
  • Répartition: N / A
  • Modèle interventionnel: Affectation à un seul groupe
  • Masquage: Aucun (étiquette ouverte)

Armes et Interventions

Groupe de participants / Bras
Intervention / Traitement
Autre: 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.
Autre: 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.

Que mesure l'étude ?

Principaux critères de jugement

Mesure des résultats
Description de la mesure
Délai
Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)
Délai: 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

Mesures de résultats secondaires

Mesure des résultats
Description de la mesure
Délai
Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)
Délai: 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)
Délai: 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

Collaborateurs et enquêteurs

C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.

Parrainer

Derming SRL

Publications et liens utiles

La personne responsable de la saisie des informations sur l'étude fournit volontairement ces publications. Il peut s'agir de tout ce qui concerne l'étude.

Publications générales

Liens utiles

Dates d'enregistrement des études

Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.

Dates principales de l'étude

Début de l'étude

1 novembre 2013

Achèvement primaire (Réel)

1 janvier 2014

Achèvement de l'étude (Réel)

1 janvier 2014

Dates d'inscription aux études

Première soumission

18 juillet 2014

Première soumission répondant aux critères de contrôle qualité

29 juillet 2014

Première publication (Estimation)

30 juillet 2014

Mises à jour des dossiers d'étude

Dernière mise à jour publiée (Estimation)

30 juillet 2014

Dernière mise à jour soumise répondant aux critères de contrôle qualité

29 juillet 2014

Dernière vérification

1 mars 2014

Plus d'information

Termes liés à cette étude

Mots clés

Autres numéros d'identification d'étude

  • E3013

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