Melasma Clinical Trials

Find Melasma Clinical Trials Near You

Evaluation of the Efficacy of a Cosmetic Product for the Reduction of Facial Hyperpigmentation: A Clinical, Subjective, and Instrumental Study

Status: Recruiting
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
SUMMARY

This is a single-center, single-blind clinical study designed to evaluate the efficacy of a depigmenting gel cream through clinical, subjective, and instrumental assessments. A total of 40 female participants, aged 30 to 60 years, will be enrolled and followed for 90 days while using the study product.Participants will be assigned to one of two groups. Group I will include 20 participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, representing Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Group II will include 20 participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), representing Fitzpatrick skin phototypes II to V. The study aims to evaluate the product's effectiveness in reducing facial hyperpigmentation and improving skin appearance over the treatment period.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 30
Maximum Age: 60
Healthy Volunteers: t
View:

• Female participants aged 30 to 60 years.

• Group I: Participants with Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype category. Participants with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines.

• Group II: Participants with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), and Fitzpatrick skin phototypes II to V.

• Willingness to comply with all study procedures and attend scheduled on-site visits and assessments.

• Willingness to comply with study procedures and be available for remote contact (telehealth) at scheduled times.

• Ability to understand the study requirements, provide written informed consent, and sign the informed consent form.

Locations
Other Locations
Brazil
Grupo Medcin
RECRUITING
Osasco
Contact Information
Primary
Beatriz Santos Arnoni
beatriz.arnoni@medcin.com.br
+55 (11) 94742 3610
Time Frame
Start Date: 2026-07-13
Estimated Completion Date: 2027-01-21
Participants
Target number of participants: 40
Treatments
Experimental: Facial Hyperpigmentation Group
Female participants aged 30 to 60 years with facial hyperpigmentation, including post-inflammatory hyperpigmentation and solar lentigines, Fitzpatrick skin phototypes I to VI, with at least one participant from each phototype. Participants will use the depigmenting gel cream for 90 days.
Experimental: Melasma Group
Female participants aged 30 to 60 years with moderate or greater melasma, as assessed by the modified Melasma Area and Severity Index (mMASI), Fitzpatrick skin phototypes II to V. Participants will use the depigmenting gel cream for 90 days.
Related Therapeutic Areas
Sponsors
Leads: Brainfarma Industria Química e Farmacêutica S/A

This content was sourced from clinicaltrials.gov