post-inflammatory hyperpigmentation
Conditions
Interventions
To compare the brightening efficacy in hyperpigmentation of two dermocosmetic products (Isobutylamido Thiazolyl Resorcinol versus Niacinamida) in facial spots. This is a randomized, blinded controlled
E02.547.800.500 J01.516.213.249
Sponsors
Allergisa Research Institute
BDF Nivea Ltda
Eligibility
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Healthy study subjects; intact skin on test site; agreement to adhere to the procedures and requirements of the study and to report to the institute on the day(s) and at the time(s) scheduled for the assessments; ability of giving consent for participation in the study; aged from 18 to 65 years old; female study subjects; subjects presenting phototype (Fitzpatrick) I to II, III, IV and V to VI; with homogeneous distribution between them 50% of subjects presenting melasma of any intensity on both half faces; according to the Institute scale; solar lentigo confirmed by a dermatologist
Exclusion criteria
Exclusion criteria: Intense sun exposure or tanning session within one month before the initial assessment or intention of being intensely exposed to sunlight or tanning sessions during the study period; presenting intense tanning signs, according to assessment of study physician; aesthetic and/or dermatological treatment performed on the face within 02 months before initial visit; beginning or change of hormone replacement treatment or medication contraception method within the last 03 months; pregnancy or breastfeeding; skin pathology on the product application site; type 1 Diabetes Mellitus: insulin-dependent diabetes, presence of complications resulting from diabetes (retinopathy, nephropathy, neuropathy); presence of dermatosis related to diabetes (lipoidic necrobiosis, plantar ulcer, ring granuloma, opportunistic infections); antecedents of episodes of hypoglycemia, diabetic ketoacidosis and/or hyperosmolar coma; immunological Insufficiency; current use of the following topical or systemic medications: corticosteroids, immunosuppressive and anti-histaminic drugs; skin diseases as vitiligo, psoriasis, atopic dermatitis; history of reaction to the category of the product tested; other diseases or medications that might directly interfere with the study or put the subject's health under risk
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| It is expected to find a statistically significant percentage reduction, of at least 10% of hyperpigmentation after 90 days period, verified by instrumental image analysis method and by colorimetric instrumental analysis. The values of these instrumental measurements will verify that the outcome occurred. | — |
Secondary
| Measure | Time frame |
|---|---|
| It is expected to verify a statistical difference in effectiveness between the two products tested for reducing hyperpigmentation. This verification will be done through statistical analysis of data generated by instrumental image analysis and colorimetric measurement. Statistical analysis will make it possible to assess whether the outcome occurred. | — |
Countries
Brazil
Contacts
Public ContactCristina Vendruscolo
Beiersdorf
Outcome results
None listed