Efficacy and Tolerability of the Tested Formula After 3 Months in Treatment of Facial Hyperpigmentation of 3 Origins

NCT06268496 | Recruiting

• 1 other identifier: LRP23021-A serum
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hyperpigmentation

Keywords

facial hyperpigmentation; melasma; acne induced PIHP; solar lentigo

Outcome Measures

Primary Outcomes (4)

• IGA score for patients with melasma or acne induced post-inflammatory hyperpigmentation (PIHP)

  the hyperpigmentation is measured on a scale from 0 (cleared, almost cleared) to 3 (severe (markedly darker than the surrounding normal skin))

  from baseline to Day84

• modified Melasma Area and Severity Index (mMASI) for patients with melasma

  the mMASI is calculated using 3 components: four regions of the face (forehead, right malar, left malar and chin); area of involvement for each region (using a scale from 0 to 6); darkness compared to the surrounding normal skin for each area (evaluated using a scale from 0 to 6)

  from baseline to Day84

• Post-Acne Hyperpigmentation Index (PAHPI)

  The PAHPI total score is the sum of all 3 weighted scores: median lesion size (from 2 \[\< 3mm\] to 8 \[\> 10mm\], median lesion intensity (from 3 \[slightly darker than surrounding skin\] to 9 \[significantly darker than surrounding skin\] and number of lesions (from 1 \[1-15\] to 5 \[\> 60\]. Total score ranges from 6 to 22.

  from baseline to Day84

• solar lentigo pigmentation scale

  the solar lentigo pigmentation scale evaluates the pigmentation using the following scale: from 0 (no pigmentation) to 10 (brown+)

  from baseline to Day84

Secondary Outcomes (1)

• colorimetry measurements

  from baseline to Day84

Study Arms (3)

mild to moderate melasma

EXPERIMENTAL

adult patients suffering from mild to moderate melasma (Investigator's Global Assessment (IGA) 1 or 2)

Other: serum formula 2039125 03

mild to moderate acne induced PIHP

EXPERIMENTAL

adult patients suffering from mild to moderate acne-induced PIHP (IGA 1 or 2) without active acne (i.e., less than 10 inflammatory lesions)

Other: serum formula 2039125 03

solar lentigo

EXPERIMENTAL

adult patients suffering from solar lentigo with a pigmentation score \> 5

Other: serum formula 2039125 03

Interventions

serum formula 2039125 03 OTHER

application twice a day of the tested product (in the morning and evening) to the face for 3 months

mild to moderate acne induced PIHP; mild to moderate melasma; solar lentigo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• all phototypes
• only one of the following pigmentary conditions on the face: epidermal or mixed, mild to moderate melasma; mild to moderate acne-induced PIHP; solar lentigo
• female patient of childbearing potential must use one of the reliable methods of contraception and agree not to change it during the study
• patient agreeing not to be exposed to ultraviolet radiation (UV), natural (sun) or artificial (tanning salon), during the study

You may not qualify if:

• female patient who gave birth less than 3 months prior to Day 0, who is pregnant, breast-feeding or who plans to become pregnant during the study
• male patient with beard or facial hair, which would interfere with clinical evaluation or clinical procedure baseline)
• patient with any inflammatory dermatosis of the face such as seborrheic dermatitis, rosacea etc.
• severe melasma, dermal melasma
• patient who has used topical depigmenting agents such as hydroquinone and derivatives, glycolic acid, kojic acid, retinoids and derivatives, azelaic acid, niacinamide within 1 month prior to Day 0/Baseline visit
• patient who has used systemic treatments such as tranexamic acid and oral melatonin within 1 month prior to Day 0/Baseline visit;
• patient who has used drugs inducing pigmentation such as tetracyclines, fluoroquinolones, antiepileptics within 1 month prior to Day 0/Baseline visit

Sponsors & Collaborators

• Cosmetique Active International: lead

Study Sites (1)

Medcin Instituto da Pele Ltda

Osasco, Brazil

RECRUITING

MeSH Terms

Conditions

Hyperpigmentation; Melanosis

Condition Hierarchy (Ancestors)

Pigmentation Disorders; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Sergio Schalka

  Medcin Instituto da Pele Ltda

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Sergio Schalka

CONTACT

+55 (11) 3683-5366; sergio.schalka@medcin.com.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2024
• First Posted: February 20, 2024
• Study Start: March 14, 2024
• Primary Completion: July 1, 2024
• Study Completion: July 1, 2024
• Last Updated: July 12, 2024

Record last verified: 2024-07

Locations

BR (1)