Clinical Trials Logo

Clinical Trial Summary

The objective of this study is to evaluate the efficacy, cosmetic acceptability and improvement of the stigmatization of the tested product (2039125 03) used bis in die (BID) for 3 months in adult patients suffering from mild to moderate melasma, or mild to moderate acne induced post-inflammatory hyperpigmentation, or solar lentigo.


Clinical Trial Description

Hyperpigmentation is a common skin condition in which the colour of the skin becomes darker. These changes result from an excess of melanin production, distribution, or transport which can be caused by various internal and external factors such as genetic predisposition, hormonal changes, inflammation, acne, ultraviolet (UV) exposure. Typical hyperpigmentation disorders include post-inflammatory hyperpigmentation, melasma and solar lentigines. This open, single-centre, three-arm study is carried out with a new cosmetic formulation developed with the aim of acting on facial hyperpigmentation and used under normal conditions of use with before/after comparisons. This clinical trial is conducted in accordance with the protocol, the HELSINKI declaration (1964) and subsequent amendments, and/or the International Council on Harmonization (ICH) Good Clinical Practices (GCP)/ and in compliance with applicable regulatory requirements. Statistical Analysis: - Efficacy Analysis: in each group, the quantitative parameters are analyzed using a mixed-effect model. This model includes Time and baseline as fixed effects. Patient are added as random effect. The comparisons between post-baseline time-point and baseline are performed whatever the interaction results using a Dunnett adjustment. Degrees of freedom for the comparisons are approximated by the Kenward-Roger method. - Safety Analysis: no statistical analysis will be performed on safety. The data are presented descriptively. Categorical data are summarized using the number and percentage of patients in each category. Continuous data are summarized using the arithmetic mean, Standard Deviation (SD), Q1, Q3, minimum, median and maximum values. Regarding the sample size determination, there was no formal calculation. A number of 20 patients in each group (i.e. 60 patients in total) was considered sufficient to meet the study objective. ;


Study Design


Related Conditions & MeSH terms


NCT number NCT06320314
Study type Interventional
Source Cosmetique Active International
Contact Pedro Pinto
Phone +351 216034267
Email geral@phdtrials.com
Status Recruiting
Phase N/A
Start date February 19, 2024
Completion date May 22, 2024

See also
  Status Clinical Trial Phase
Completed NCT04586816 - Randomized, Double-Blind Evaluation of Maple Leaf Extract (Maplifa) for Photoaging N/A
Completed NCT06000839 - A Safety and Effectiveness Study of CELLBOOSTER® Lift (Stabilized Booster Complex Using CHAC Technology) N/A
Completed NCT02138539 - Evaluation of an Herbal-Based De-Pigmenting System Phase 4
Recruiting NCT05362929 - Efficacy and Tolerability of a Hybrid Fractional Laser for the Treatment of Acne Scars in Patients With Skin of Color N/A
Completed NCT06031116 - Efficacy of Ceramic Soft Tissue Trimming Bur Versus Conventional Scalpel Technique in Ginigival Depigmentation Procedure N/A
Recruiting NCT04765930 - Combined Q-switched Nd:YAG Laser and Platelet Rich Plasma Versus Q- Switched Nd:YAG Laser Alone in Melasma N/A
Active, not recruiting NCT05493280 - Fractionated 1927nm Laser for Hyperpigmentation in Fitzpatrick Skin Phototypes V and VI N/A
Recruiting NCT06253455 - Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins N/A
Not yet recruiting NCT06080035 - The Effects of Cetyl Tranexamate Mesylate on the Appearance of Acne-Related Hyperpigmentation N/A
Completed NCT03457246 - Efficacy and Tolerance of D-pigment Versus Moisturizer in Hands' Lentigo Lesions With or Without Laser Therapy N/A
Completed NCT04619589 - Characterization of Dyschromic Hypertrophic Scar
Recruiting NCT05165524 - Brightening Cream and Lasers in Post-sclerotherapy Hyperpigmentation N/A
Not yet recruiting NCT06268496 - Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins N/A
Not yet recruiting NCT06253468 - Efficacy and Tolerability of Tested Formula After 3 Months of Treatment of Facial Hyperpigmentation of 3 Origins N/A
Completed NCT05423873 - A Multi-Center, Open-label Study Evaluate the Efficacy and Tolerability of a Dual Skincare Regimen Treatment for Facial Hyperpigmentation and Photodamaged Skin in Patients Exposed to Extrinsic Factors of Aging N/A
Completed NCT01149876 - Study to Evaluate the Effect of a Nu Skin Product and Device for Brown Spots Phase 4
Completed NCT01542138 - Clinical Trial of 4% Niacinamide Versus 0.05% Desonide for the Treatment of Axillar Hyperpigmentation Phase 4
Completed NCT04704245 - Effectiveness of Epidermal Growth Factor-containing Ointment on the Solar Lentigines N/A
Completed NCT06189768 - A Study on Pigmentation Disorders in Children
Completed NCT06103461 - Fat Grafting an Ideal Filler For Contour Deformities With Hyperpigmentation On Face N/A