Anti-aging Repairing Serum: Efficacy and Tolerability Study

NCT ID: NCT06059274

Last Updated: 2023-10-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-14

Study Completion Date

2018-06-07

Brief Summary

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The study aimed to evaluate the effectiveness and tolerability of a dermocosmetic serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water in reducing skin aging signs. The experimental clinical trial involved 34 participants aged 45 to 65 years who applied the serum twice a day for 84 days.

Detailed Description

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This experimental, mono-centric, open clinical trial was conducted in accordance with the principles of Resolution 466/2012 of the Conselho Nacional de Saúde do Brasil, ethical principles from the Declaration of Helsinki (and subsequent modifications) and Good Clinical Practice (GCP).

Quality control was applied to each stage of data handling to ensure that clinical data were generated, collected, processed, analyzed and reported according to the protocol, Standard Operating Procedures (SOP) and requirement of GCP.

Descriptive Statistics: Quantitative parameters, or those that can be reasonably treated as such, were summarized using measures of central tendency as mean and median and dispersion measures as standard deviation at each time of evaluation. Quantitative variables were summarized using frequencies and percentages. For each parameter (clinical evaluation scores and parameters derived from the Primos®) and each region (frontal, periocular, peri-oral and neck), graphical representations of means ± 95% Confidence Interval (CI) were elaborated for visual assessment of evolution over time.

Conditions

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Anti-aging

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Topical serum

An investigational topical serum containing hyaluronic acid, vitamin B5, madecassoside and La Roche-Posay Thermal Spring Water

Group Type EXPERIMENTAL

Topical serum

Intervention Type OTHER

Participants are asked to apply the topical serum twice daily for 84 days.

Interventions

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Topical serum

Participants are asked to apply the topical serum twice daily for 84 days.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* phototype I to IV
* presenting wrinkles on the forehead and/or peri-orbital area with grade ≥ 2 and ≤4 according to "Skin Aging Atlas"
* participant has not used any anti-aging products or performed aesthetic procedures over the last three months

Exclusion Criteria

* pregnant, breastfeeding or immune compromised woman
* participant with cutaneous marks or active dermatoses on the tested area that could interfere with the evaluation
Minimum Eligible Age

45 Years

Maximum Eligible Age

65 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Cosmetique Active International

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Joana Carvalho

Role: PRINCIPAL_INVESTIGATOR

Centre International de Développement Pharmaceutique (CIDP)

Locations

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CIDP Brasil

Rio de Janeiro, , Brazil

Site Status

Countries

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Brazil

Other Identifiers

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1718CBCL357-Serum

Identifier Type: -

Identifier Source: org_study_id

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