This clinical study aims to evaluate the effects of using the cosmetic product TRIDERM D.S. Crema Normalizzante in children aged 0 to 3 years with neonatal hyperseborrhea ("cradle cap"), potentially associated with manifestations of mild-to-moderate seborrheic dermatitis. The study will assess whether use of the product is associated with an improvement in the clinical signs of the condition, particularly scaling and erythema, and will evaluate its cutaneous tolerability. Caregiver-perceived improvement, as well as additional dermatological, photographic, and instrumental assessments, will also be considered.
Age from 0 to 3 years.
Good general health.
Clinical diagnosis of neonatal hyperseborrhea ("cradle cap"), including possible cutaneous manifestations associated with mild-to-moderate seborrheic dermatitis.
No use of keratolytic, anti-inflammatory, or antifungal treatments within the 15 days prior to enrollment.
Presence of other concomitant dermatological conditions that, in the Investigator's judgment, may interfere with the clinical assessment of the study.
Presence of seborrheic dermatitis of greater severity than that specified in the inclusion criteria.
Use of specific topical treatments (keratolytics, corticosteroids, or antifungals) on the affected areas within the 15 days prior to enrollment.
Participation in another clinical study within the 30 days prior to enrollment.
Single group
TRIDERM D.S. Crema Normalizzante
Other interventionTRIDERM D.S. Crema Normalizzante is a topical cosmetic product intended for use as a cosmetic adjunct in the presence of skin manifestations associated with seborrheic dermatitis. The product will be applied to the affected skin areas according to a two-phase regimen: an intensive phase consisting of two applications per day for 10 consecutive days, followed by a maintenance phase consisting of two applications per day on 3 days per week for the subsequent 2 weeks. After completion of the 24-day product-use period, no further product application will be performed during the 28-day follow-up period.
Change From Baseline in Investigator's Global Assessment (IGA) Score
Clinical improvement will be assessed using the Investigator's Global Assessment (IGA), a 5-point scale ranging from 0 to 4: 0 = absent, 1 = very mild, 2 = mild, 3 = moderate, and 4 = severe. The IGA provides an overall assessment of the intensity and extent of the clinical manifestations, with particular consideration of scaling and erythema. Change in IGA score from baseline (T0) will be assessed at subsequent study visits. A decrease in the IGA score indicates clinical improvement.
Change From Baseline in Erythema Score
Erythema will be assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of erythema, 1 very mild erythema, 2 mild erythema, 3 moderate erythema, and 4 severe erythema. Higher scores indicate greater severity/worse outcome. Change from baseline in erythema score will be evaluated at each post-baseline study time point.
Change From Baseline in Scaling Score
Scaling will be assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of scaling, 1 very mild scaling, 2 mild scaling, 3 moderate scaling, and 4 severe scaling. Higher scores indicate greater severity/worse outcome. Change from baseline in scaling score will be evaluated at each post-baseline study time point.
Percentage of Participants With at Least a 1-Point Change From Baseline in Investigator's Global Assessment (IGA) Score Toward Lower Severity
Participants will be classified as meeting the clinical response criterion if they have at least a 1-point change from baseline in the Investigator's Global Assessment (IGA) score toward lower severity at a post-baseline study time point. The IGA is assessed by the Clinical Investigator using a 5-point semiquantitative clinical severity scale ranging from 0 to 4, where 0 indicates absence of disease signs, 1 very mild, 2 mild, 3 moderate, and 4 severe. Higher scores indicate greater severity/worse outcome. The percentage of participants meeting this criterion will be calculated at each post-baseline study time point.
Investigator's Global Assessment of Clinical Improvement Compared With Baseline
The Clinical Investigator will provide an overall assessment of clinical improvement compared with baseline (T0). At each post-baseline assessment, the participant's overall clinical condition will be classified as improved, unchanged, worsened, or not evaluable compared with baseline.
Number and Percentage of Participants by Clinical Investigator's Overall Wood's Lamp Assessment Category Compared With Baseline
Affected skin areas will be assessed by the Clinical Investigator using a Wood's lamp. The assessment will include clinical observation of fluorescence-related findings, such as presence or absence of fluorescence, qualitative changes in fluorescence color or intensity, fluorescence distribution, and estimated extent of the fluorescent area. These observations will be used to assign one overall categorical Wood's lamp assessment compared with baseline at each post-baseline visit. Categories will be: improved, unchanged, worsened, or not evaluable. The number and percentage of participants in each category will be summarized at each post-baseline study time point.
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
