Cosmetic gel for facial hyperpigmentation in women

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a single-center, single-blind interventional study enrolling 40 women with facial hyperpigmentation or melasma. Participants are divided into two groups and use the depigmenting gel for 90 days, with clinical, subjective, and instrumental assessments to measure changes in pigmentation and appearance. The study will include a range of skin phototypes and uses standard criteria like mMASI to categorize melasma severity. Safety monitoring and adherence will be collected through visits and remote contact.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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.

Exclusion Criteria:

* Pregnant or breastfeeding women, or women at risk of becoming pregnant during the study.
* Use of anti-inflammatory, immunosuppressive, or antihistamine medications within 3 weeks prior to screening.
* Skin conditions or marks in the study area that may interfere with the evaluation of skin reactions, including vascular malformations, scars, excessive hair growth, multiple nevi, or sunburn.
* History of atopic conditions or allergy to cosmetic products.
* Active skin diseases and/or lesions in the assessment area.
* Immunosuppression due to medication use or active disease.
* Uncontrolled endocrine disorders.
* Relevant medical history or current evidence of alcohol or substance abuse.
* Known history or suspected intolerance to products of the same category as the study product.
* Intense sun exposure within 15 days prior to assessment.
* Aesthetic or dermatological treatments within 4 weeks prior to assessment.
* Any other condition that, in the investigator's opinion, may interfere with study participation or justify exclusion from the study.

Where it's running

• Grupo Medcin
  Osasco, São Paulo, Brazil Recruiting

Study contacts

• Principal investigator: Sergio Schalka — Grupo Medcin
• Study coordinator: Layane Melody Da Silva Reis Cavalcante
• Email: layane.reis@brainfarma.ind.br
• Phone: +55 (11) 4507-2183

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.