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Completed

NCT Number: NCT02204436

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

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.

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Key information

Conditions

Healthy Hyperpigmentation Pigmentation Disorders Skin Diseases Skin and Connective Tissue Diseases

Age range

45 year–65 year

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

DermIng SRL

Monza, 20900, Italy

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Emulsion and gel

Other

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.

Primary outcomes

  1. Skin spots image analysis: change from baseline (T2, T4 and T8 vs. T0)

    Time frame: 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).

Secondary outcomes

  1. Spectrophotometric evaluation: change from baseline (T2, T4 and T8 vs. T0)

    Time frame: 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.

  2. Optical colorimetry: change from baseline (T2, T4 and T8 vs. T0)

    Time frame: 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).

Sponsors and collaborators

Lead sponsor

Derming SRL

Other

Registry information

Important dates

Study start
2013
Primary completion
2014
Study completion
2014
First posted
Jul 30, 2014
Registry last updated
Jul 30, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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