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Clinical and Biological Anti-aging Efficacy of a Cosmetic Cream

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Pierre Fabre

Status

Completed

Conditions

Anti-aging

Treatments

Other: Anti-aging cosmetic care product

Study type

Interventional

Funder types

Industry

Identifiers

NCT05895591
RV4981A20210184

Details and patient eligibility

About

The aim of the study is to determine the efficacy of the investigational product "Cream " :

  • on skin network after 56 days of daily application
  • on biological parameters linked to cellular communication involved in senescence
  • on sebum composition (metagenomics and metabolomics analysis)

Full description

This study will be conducted as a monocentric, randomized (for side of product application on forearms), open trial.

4 visits are planned:

  • Visit 1 - Inclusion (D1)
  • Visit 2 - Follow-up visit (D29), a window of +72 hours is allowed for this evaluation,
  • Visit 3 - End of the application period (D57), a window of +72 hours is allowed for this evaluation
  • Visit 4 - Follow-up visit (D7 post-biopsies +/- 24h)

For a subject completing the study, the theoretical investigational product application will be 56 consecutive days up to 59 days maximum.

The study duration for each subject will be 67 days maximum.

Enrollment

33 patients

Sex

Female

Ages

35 to 55 years old

Volunteers

Accepts Healthy Volunteers

Inclusion criteria

  • sensitive skin (declaratory judgment)
  • face skin type: combination to normal skin
  • presenting wrinkles and/or finelines on the whole face
  • displaying saggy skin on the face (loss of firmness)
  • presenting a lack of skin radiance, dull complexion and an inhomogeneous skin on the face

Exclusion criteria

Related to the treatment/product:

  • having had any surgery, chemical or significant invasive dermo-treatment on the experimental area considered by the Investigator liable to interfere with the study data
  • having undergone techniques with aesthetic aim on study areas (chemical peel, mechanical dermabrasion, laser, pulsed flash lamp etc.) or having made injections of anti-wrinkle products (collagen, hyaluronic acid, botulinic toxin etc.)
  • having applied products with an anti-aging action (Retinoic acid, retinol, retinaldehyde, A.H.A. etc.)

Trial design

Primary purpose

Prevention

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

33 participants in 1 patient group

Treated Group
Experimental group
Description:
all subjects will apply the study product
Treatment:
Other: Anti-aging cosmetic care product

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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