Tested Formula vs. Hydroquinone for Facial Melasma Treatment
Experimental: Group TP
+ Active Comparator: Group HQ: Hydroquinone 4%
Melanosis+2
+ Pigmentation Disorders
+ Skin Diseases
Other Study
Summary
Study start date: August 17, 2023
Actual date on which the first participant was enrolled.This study aims to compare a new facial serum to hydroquinone 4% in treating facial melasma, a common skin condition causing dark patches on the face. Hydroquinone is the most commonly used treatment for reducing skin discoloration and is often combined with other topical medications. The study's goal is to determine if the new serum is as effective or even better than hydroquinone in improving melasma symptoms. It involves participants with facial melasma and helps address the need for alternative treatments that are effective and well-tolerated. Participants in this study are divided into two groups, with one group receiving the new serum and the other receiving hydroquinone 4%. The treatment is applied topically, meaning it is put directly on the skin, over a period of three months. The effectiveness is measured by changes in the Melasma Area Severity Index, a tool used to assess the severity of melasma, after 84 days. Safety data is collected but not analyzed statistically, ensuring the focus remains on the treatment's efficacy. The study includes 104 participants, with equal numbers in each group, to ensure reliable results.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.109 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Other Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.Female
Biological sex of participants that are eligible to enroll.From 18 to 50 Years
Range of ages for which participants are eligible to join.Healthy volunteers allowed
If individuals who are healthy and do not have the condition being studied can participate.Conditions
Pathology
Criteria
Inclusion Criteria: 1. Women; 2. Adults (over 18 y.o.) (preference 18-50 y.o.); 3. Phototypes I to IV; 4. Melasma epidermal or mixed (exclude dermal melasma); 5. Ready to protect as much as possible from the sun for the duration of the study; 6. Ready to avoid contraindicated products (irritants, other depigmenting agents); 7. Participants demonstrating understanding of the study procedures, restrictions, and willingness to participate as evidenced by voluntary written informed consent and having received a signed and dated copy of the informed consent form. Exclusion criteria 1. Subjects with dermal melasma (wood lamp at inclusion); 2. Subjects who has already use of hydroquinone 4% in the past year; 3. Subjects with stable hormonal therapy (contraceptive ou THS) for at least 6 months; 4. Pregnant or breastfeeding women or pregnancy plans; 5. Subjects applying irritants (such as peeling, acid..) (2 weeks wash out); 6. Subjects under active treatment of melasma (including topicals or procedures) within the last 2 weeks; 7. Subjects using drugs that can induce melasma such as antiepileptics (1 month wash out); 8. Subjects using other products claiming a depigmenting activity (1 month wash out); 9. Subjects with other dermatosis of the face or known photosensitivity; 10. All types of topical treatment applied to the face (wash out of 2 weeks) 11. Subjects without any facial procedure planned during the course of the study 12. Subjects under phototherapy (1 month wash out) 13. Subjects hypersensitivity to the products of the study 14. Any history of significant dermatological/ophthalmological diseases or conditions or medical conditions known to alter skin appearance or physiologic response (e.g. diabetes,) which could, in the opinion of the Investigator, preclude topical application of the investigational products and/or interfere with the evaluation of the test site reaction 15. Subjects currently using any medication, which in the opinion of the investigator, may affect the evaluation of the study product, or place the subject at undue risk. 16. Previous history of atopy, allergic reactions, irritation or intense discomfort feelings to topical-use products, cosmetics, or medication 17. Participation in another clinical study 18. Employee of the sponsor or the study site
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.2 intervention groups are designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalGroup II
Active ComparatorStudy Objectives
Primary Objectives
Secondary Objectives
Study Centers
These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.This study has 1 location