TRIDERM D.S. Crema Normalizzante for Neonatal Hyperseborrhea (Cradle Cap) and Associated Cutaneous Manifestations of Mild-to-Moderate Seborrheic Dermatitis in Children Aged 0 to 3 Years

Participants assigned to this single experimental arm will receive the cosmetic product TRIDERM D.S. Crema Normalizzante. The product will be applied twice daily for 10 days during the intensive phase, followed by a maintenance phase consisting of twice-daily application on 3 days per week for the subsequent two weeks. After completion of the product-use period, participants will undergo a 28-day follow-up period without product application.

TRIDERM 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.

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.

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.

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.

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.

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.

Local cutaneous reactions will be assessed based on events observed by the Clinical Investigator or reported by the participant's parent or legal guardian during the study. Local cutaneous reactions may include erythema, irritation, pruritus, or other skin reactions at the application site. For each reaction, the description, onset date, duration, intensity, location, relationship to the study product, action taken, and outcome will be recorded in the case report form. The number and percentage of participants with at least one local cutaneous reaction will be summarized.

Caregivers will complete a structured parent/legal guardian product evaluation questionnaire assessing perceived improvement in the participant's cutaneous manifestations, child comfort/tolerability, cosmetic acceptability, product use experience, overall satisfaction, and willingness to purchase or recommend the product. The perceived improvement section includes items assessed using a 5-point agreement scale ranging from 1 to 5, where 1 indicates "not at all agree" and 5 indicates "completely agree"; higher scores indicate a more favorable caregiver-reported perception of improvement. Other questionnaire items use categorical response options and will be summarized descriptively as counts and percentages by response category. No total questionnaire score is planned.

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.