Melasma Skin and Connective Tissue Diseases
Conditions
Interventions
Participants were randomized by simple randomisation using Microsoft Excel into two groups:
Group A: 40 participants used facial serum + facial sunscreen.
Group B: 40 participants used 4% hydroquinone
Sponsors
Isdin (Spain)
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1. Female participants aged from 35 to 65 years old 2. Participants with all skin types (dry, normal, combination or oily) 3. Participants with moderate to severe melasma for at least 1 year, without treatment for at least 3 months (mMASI Scale) 4. User of cosmetic products in the same category 5. Willing to follow the trial procedures and attend the clinic on the days and times determined for evaluations 6. Understanding, consenting and signing the Informed Consent Form (ICF)
Exclusion criteria
Exclusion criteria: 1. Participants who have been diagnosed with COVID-19 by RT-PCR test or by the presence of IgM antibodies in serology test within the last 4 weeks or who are experiencing any of the following symptoms: dry or productive cough, sneezing, runny nose, body pain, headache, anosmia (loss of smell), ageusia (loss of taste) and/or any other symptom that may be related to COVID-19, at the investigator's discretion 2. Pregnancy or at risk of pregnancy/lactation 3. Using anti-inflammatory/immunosuppressive/antihistamine drugs up to 3 weeks before selection 4. Skin spots in the experimental site that interfere with the assessment of possible skin reactions (vascular malformations, scars, increased hairiness, large amounts of nevus, sunburn) 5. History of atopy or allergy to cosmetic products 6. Active skin pathologies and/or lesions (local and/or disseminated) in the assessment site 7. Immunosuppression by drugs or active diseases 8. Decompensated endocrinopathy 9. Relevant medical history or current evidence of alcohol or other drug abuse 10. Known history or suspected intolerance to products in the same category 11. Intense exposure to sunlight up to 15 days before the assessment 12. Aesthetic or dermatological treatment up to 4 weeks before the assessment 13. Other conditions considered by the researcher as reasonable for disqualification from participation in the study (it should be described as observations in the clinical record).
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The non-inferiority of the dermocosmetic product compared to 4% hydroquinone cream in the treatment of facial melasma, measured using the Modified Melasma Area and Severy Index (mMASI) after 30 (D30) and 90 (D90) days of continuous use and 1 month after discontinuation of treatment (D120) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The clinical efficacy of products in lightening facial melasma assessed using the Modifed Melasma Area and Severy Index (mMASI) after 30 (D30) and 90 (D90) days of continuous use and 1 month after discontinuation of treatment (D120) 2. The intensity of skin blemishes assessed using the Chromameter® after 30 (D30) and 90 (D90) days of continuous use and 1 month after discontinuation of treatment (D120) 3. The perceived effectiveness of products from the target audience's point of view and the improvement in the quality of life of participants with melasma, measured using the Melasma Quality of Life (MELASQoL) scale and subjective questionnaire after 30 (D30) and 90 (D90) days of continuous use and 1 month after discontinuation of treatment (D120) | — |
Countries
Brazil
Contacts
Public ContactGeorgina Logusso
Outcome results
None listed