Cradle CapNCT07860788
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
A study testing TRIDERM D.S. Crema Normalizzante in people with Cradle Cap and Seborrheic Dermatitis, run by ICIM International S.r.l. at 1 site in Italy.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 0 to 3 years
- Conditions the study is for
- Cradle Cap, Seborrheic Dermatitis
- What is being tested?
- TRIDERM D.S. Crema Normalizzante
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteItaly
- Study dates
- Oct 2026to Feb 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 0 to 3 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
- Written informed consent provided by the participant's parent(s) or legal guardian.
Who cannot join
- 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.
- Known or suspected hypersensitivity to one or more components of the study product.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Dr. Cesare Filippeschi, Medical Doctor contact
Italy1 site
Meyer Children's Hospital IRCCS
Florence, Tuscany, 50139
Dr. Teresa Oranges, Medical Doctor, 3534857430, teresa.oranges@meyer.it
About this study
Official title: Prospective, Interventional, Single-Center, Single-Arm Clinical Study to Evaluate the Clinical Improvement of Neonatal Hyperseborrhea ("Cradle Cap"), Including Potential Cutaneous Manifestations Associated With Mild-to-Moderate Seborrheic Dermatitis, and the Cutaneous Tolerability of the Cosmetic Product TRIDERM D.S. Crema Normalizzante.
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.
Read the detailed description
This is a prospective, interventional, single-center, single-arm clinical study conducted at Meyer Children's Hospital IRCCS in Florence, Italy. The study is expected to enroll 20 pediatric participants aged 0 to 3 years.
Neonatal hyperseborrhea, commonly referred to as "cradle cap," is a frequent condition during the first months of life and may also occur in association with manifestations of seborrheic dermatitis. As part of the non-pharmacological topical management of these manifestations, cosmetic products may be used to help improve visible skin signs without exerting a pharmacological action.
TRIDERM D.S. Crema Normalizzante is a cosmetic product intended for use as a cosmetic adjunct in the presence of manifestations associated with seborrheic dermatitis. In this study, the product will be applied according to a regimen consisting of an intensive phase, with two applications per day for 10 days, followed by a maintenance phase, with two applications per day on 3 days per week for the subsequent two weeks. At the end of the product-use period, a follow-up period without product application is planned.
There will be no control group or comparator product. Assessments will be performed longitudinally within each participant by comparing the condition observed at baseline with that observed during product use and at follow-up. The overall duration of participation for each participant will be approximately 52 days. The study is exploratory and preliminary in nature and is intended to generate clinical data to support the scientific documentation and cosmetic claims related to the product.
- Conditions
- Cradle Cap, Seborrheic Dermatitis
- Being tested
- TRIDERM D.S. Crema Normalizzante
- Keywords
- Neonatal hyperseborrhea, Infantile seborrheic dermatitis, Cradle cap, Scaling, Erythema, Pediatric dermatology, Cosmetic product, Cutaneous tolerability, TRIDERM D.S. Crema Normalizzante
- Medical subject headings
- Dermatitis, Seborrheic, Complement component 5 deficiency, Erythema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TRIDERM D.S. Crema NormalizzanteOther
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.
| Study group | Role | What they receive |
|---|---|---|
| TRIDERM D.S. Crema Normalizzante | Experimental | 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. Receives: Other: TRIDERM D.S. Crema Normalizzante |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Secondary outcomes (6)
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.
Measured: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
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.
Measured: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
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.
Measured: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
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.
Measured: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Number and Percentage of Participants With Local Cutaneous Reactions
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.
Measured: From baseline through the follow-up visit, 28 days after Day 24 (±3 days)
Caregiver-Reported Responses on the Parent/Legal Guardian Product Evaluation Questionnaire
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.
Measured: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionFeb 2027 (estimated)
- Study completionFeb 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cradle CapStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- ICIM International S.r.l.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07860788
- Sponsor's protocol ID
- TR-DSI
- Status last verified
- Sep 2026
- First submitted
- 15 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) sharing is not planned for this study. Study results may be disseminated in aggregate form, in accordance with applicable ethical and data protection requirements.
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective, Interventional, Single-Center, Single-Arm Clinical Study to Evaluate the Clinical Improvement of Neonatal Hyperseborrhea ("Cradle Cap"), Including Potential Cutaneous Manifestations Associated With Mild-to-Moderate Seborrheic Dermatitis, and the Cutaneous Tolerability of the Cosmetic Product TRIDERM D.S. Crema Normalizzante.
- ClinicalTrials.gov ID
- NCT07860788
- Acronym / sponsor ID
- TR-DSI
- Conditions
- Cradle Cap, Seborrheic Dermatitis
- Keywords
- Neonatal hyperseborrhea, Infantile seborrheic dermatitis, Cradle cap, Scaling, Erythema, Pediatric dermatology, Cosmetic product, Cutaneous tolerability
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- ICIM International S.r.l.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Feb 2027 (estimated)
- Study completion
- Feb 2027 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective, interventional, single-center, single-arm clinical study conducted at Meyer Children's Hospital IRCCS in Florence, Italy. The study is expected to enroll 20 pediatric participants aged 0 to 3 years.
Neonatal hyperseborrhea, commonly referred to as "cradle cap," is a frequent condition during the first months of life and may also occur in association with manifestations of seborrheic dermatitis. As part of the non-pharmacological topical management of these manifestations, cosmetic products may be used to help improve visible skin signs without exerting a pharmacological action.
TRIDERM D.S. Crema Normalizzante is a cosmetic product intended for use as a cosmetic adjunct in the presence of manifestations associated with seborrheic dermatitis. In this study, the product will be applied according to a regimen consisting of an intensive phase, with two applications per day for 10 days, followed by a maintenance phase, with two applications per day on 3 days per week for the subsequent two weeks. At the end of the product-use period, a follow-up period without product application is planned.
There will be no control group or comparator product. Assessments will be performed longitudinally within each participant by comparing the condition observed at baseline with that observed during product use and at follow-up. The overall duration of participation for each participant will be approximately 52 days. The study is exploratory and preliminary in nature and is intended to generate clinical data to support the scientific documentation and cosmetic claims related to the product.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TRIDERM D.S. Crema Normalizzante | Experimental | Other: TRIDERM D.S. Crema NormalizzanteParticipants 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. |
Who may qualify
- Ages
- 0 to 3 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
- Written informed consent provided by the participant's parent(s) or legal guardian.
Key exclusion criteria (5 listed)
- 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.
- Known or suspected hypersensitivity to one or more components of the study product.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TRIDERM D.S. Crema NormalizzanteTRIDERM 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. | Other | TRIDERM D.S. Crema Normalizzante |
Primary outcome
Change From Baseline in Investigator's Global Assessment (IGA) Score
Time frame: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
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.
6 secondary outcomes
Change From Baseline in Erythema Score
Time frame: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Change From Baseline in Scaling Score
Time frame: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Percentage of Participants With at Least a 1-Point Change From Baseline in Investigator's Global Assessment (IGA) Score Toward Lower Severity
Time frame: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Investigator's Global Assessment of Clinical Improvement Compared With Baseline
Time frame: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Number and Percentage of Participants With Local Cutaneous Reactions
Time frame: From baseline through the follow-up visit, 28 days after Day 24 (±3 days)
Caregiver-Reported Responses on the Parent/Legal Guardian Product Evaluation Questionnaire
Time frame: Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: No. Individual participant data (IPD) sharing is not planned for this study. Study results may be disseminated in aggregate form, in accordance with applicable ethical and data protection requirements.
Related trials for Cradle Cap
Not yet recruitingPhase 3
Efficacy and Safety of Roflumilast Foam 0.3% in Trial Participants With Seborrheic Dermatitis
Seborrheic Dermatitis
RecruitingEarly Phase 1
The Effectiveness of Itraconazole Pulse Therapy vs Topical 2% Ketoconazole in the Treatment of Moderate to Severe Seborrheic Dermatitis of Scalp.
Seborrheic Dermatitis
RecruitingPhase 1
ZYG24002 Lotion to Evaluate the Safety, Tolerability, Pharmacokinetics and Preliminary Efficacy in Adult Patients With Mild to Moderate Seborrheic Dermatitis
Seborrheic Dermatitis
Recruiting
A Study on Scalp Health and Integrated Scalp Management Protocols for Hair Transplant Patients
Hair Transplantation, Seborrheic Dermatitis
Not yet recruiting
Sebum Metabolomics and Lipidomics for Clinical Applications
Acne, Atopic Dermatitis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dr. Cesare Filippeschi, Medical Doctor contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing TRIDERM D.S. Crema Normalizzante in people with Cradle Cap and Seborrheic Dermatitis, run by ICIM International S.r.l. at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr. Teresa Oranges, Medical Doctor (+ 39 3334720816, teresa.oranges@meyer.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Investigator's Global Assessment (IGA) Score (time frame: Baseline, Day 10 (±2 days), Day 24 (±2 days), and 28 days after Day 24 (±3 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.