Dermatitis, SeborrheicPhase 1/2NCT03830177

Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult

A Phase 1/2 study testing Natural Treatment in people with Dermatitis, Seborrheic and Dry Skin; Eczema, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 1 year and olderHealthy volunteers can take part
Conditions the study is for: Dermatitis, Seborrheic, Dry Skin; Eczema
What is being tested?: Natural Treatment
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 77 participants
Where: 1 siteUnited States
Study dates: 8 Jul 2019to 4 Oct 2023
Phase: Phase 1/2
Are there results?: Yes, posted in the registrySummary in the doctors' view

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 1 year and older
All sexes
Healthy volunteers accepted
Child, Adult, Older adult

Who may be able to join

Age 1 year (or corrected age of 1 year, for those born prematurely) to 17 years for children, and adults 18 and older
Patients with dry scalp and dandruff symptoms as determined by a board-certified Dermatologist, Allergist, or Pediatrician
Good general health
Participant and/or their parents are able to read, write, and understand study materials in English

Who cannot join

Infants younger than 1 year old
Patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and pediculosis capitis
Systemic steroid or oral antibiotic use during the past two months
Allergy to any of the preparation components

Trial locations and contacts

1 site in 1 country.

United States1 site

Medical Dermatology Associates of Chicago
Chicago, Illinois, 60654

Other trials in United States

About this study

Official title: Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults

The purpose of this study is to evaluate the safety and efficacy of a novel topical treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. The study investigates clinical improvements in symptom severity, participant experience with the treatment, and changes in the scalp microbiome before and after use. By studying this treatment, the investigators aim to provide children and adults with a natural, effective option for managing dry scalp conditions.

Read the detailed description

This study evaluates the safety and efficacy of a novel topical scalp treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. The treatment contains Lactobacillus sp., honey, and turmeric in an emollient base, hypothesized to alleviate symptoms by addressing microbial imbalances, reducing inflammation, and promoting scalp hydration.

The study will enroll 15-40 pediatric participants aged 1-17 years and 20-40 adults aged 18 and older, all clinically diagnosed with dry scalp. All participants will apply the treatment over a 14-day period. Adults will use the treatment daily, while pediatric participants will apply it 2-3 times weekly. Other scalp therapies will be discontinued during the study period.

The study aims to explore the treatment's potential to improve clinical severity, enhance quality of life, and positively impact the scalp microbiome, providing a natural, effective option for managing dry scalp conditions.

Conditions: Dermatitis, Seborrheic, Dry Skin; Eczema
Being tested: Natural Treatment
Medical subject headings: Dermatitis, Seborrheic, Eczema

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Natural TreatmentDrug
Also called Yobee
Participants will receive a topical treatment formulated with natural ingredients (Lactobacillus sp., honey, and turmeric) and a kit containing all necessary materials, including an instruction handout. The treatment is applied to the scalp, left for roughly 5 minutes, and rinsed off.

Study groups in NCT03830177
Study group	Role	What they receive
Intervention Arm	Experimental	All participants receive a topical scalp treatment containing Lactobacillus sp., honey, and turmeric. Adults apply the treatment daily for 14 days, while children apply it 2-3 times weekly for 14 days. Receives: Drug: Natural Treatment

What is being measured

The primary outcome is the main question the study is designed to answer.

Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Measured: Baseline, 2 weeks (Study Endpoint)
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Measured: Baseline, 2 weeks (Study Endpoint)
Efficacy Determined Using the Total Severity Scale (TSS) - Adult
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.
Measured: Baseline, 2 weeks (Study Endpoint)
Efficacy Determined Using the Total Severity Scale (TSS) - Child
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.
Measured: Baseline, 2 weeks (Study Endpoint)

Secondary outcomes (3)

Change in Bacterial Composition of Scalp Using RODAC
This exploratory outcome assesses whether the topical treatment alters the scalp microbiome to more closely resemble that of a healthy scalp. Scalp samples were collected at baseline and endpoint using swabs and analyzed with 16S ribosomal RNA (rRNA) sequencing for bacterial diversity and internal transcribed spacer (ITS) sequencing for fungal diversity. Colony counts were measured using the Replicate Organism Detection and Counting (RODAC) method to evaluate bacterial and fungal load changes.
Measured: 6 months
Quality of Life Change - Adult
Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Assessments were conducted at Baseline and after 2 weeks (Study Endpoint) to measure changes over time.
Measured: Baseline, 2 weeks (Study Endpoint)
Quality of Life Change - Child
Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Originally, assessments were to be conducted at baseline and endpoint to measure changes in quality of life. However, for children, only midpoint data were collected, so change could not be measured.
Measured: 1 week (Study midpoint)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

8 Jul 20194 Oct 2023

First posted5 Feb 2019
Study start8 Jul 2019
Primary completion11 Jan 2023
Study completion4 Oct 2023

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Dermatitis, SeborrheicStudies 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 1/2
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 77 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03830177
Sponsor's protocol ID: 2019-2309
Status last verified: Feb 2025
First submitted: 27 Nov 2018
Last updated: 24 Feb 2025
Results posted: Yes, on ClinicalTrials.gov
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults
ClinicalTrials.gov ID: NCT03830177
Acronym / sponsor ID: 2019-2309
Conditions: Dermatitis, Seborrheic, Dry Skin; Eczema
Phase: Phase 1/2
Study type: Interventional
Recruitment status: Completed
Enrolment: 77 participants (actual)
Lead sponsor: Ann & Robert H Lurie Children's Hospital of ChicagoUniversity, hospital or other
Collaborators: Northwestern University
Study start: 8 Jul 2019 (actual)
Primary completion: 11 Jan 2023 (actual)
Study completion: 4 Oct 2023 (actual)
First posted: 5 Feb 2019 (actual)
Results: Posted 24 Feb 2025

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Intervention Arm	Experimental	Drug: Natural TreatmentAll participants receive a topical scalp treatment containing Lactobacillus sp., honey, and turmeric. Adults apply the treatment daily for 14 days, while children apply it 2-3 times weekly for 14 days.

Who may qualify

Ages: 1 year and older
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (4 listed)

Age 1 year (or corrected age of 1 year, for those born prematurely) to 17 years for children, and adults 18 and older
Patients with dry scalp and dandruff symptoms as determined by a board-certified Dermatologist, Allergist, or Pediatrician
Good general health
Participant and/or their parents are able to read, write, and understand study materials in English

Key exclusion criteria (4 listed)

Infants younger than 1 year old
Patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and pediculosis capitis
Systemic steroid or oral antibiotic use during the past two months
Allergy to any of the preparation components

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
Natural TreatmentAlso: YobeeParticipants will receive a topical treatment formulated with natural ingredients (Lactobacillus sp., honey, and turmeric) and a kit containing all necessary materials, including an instruction handout. The treatment is applied to the scalp, left for roughly 5 minutes, and rinsed off.	Drug	Intervention Arm

Primary outcome

Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult
Time frame: Baseline, 2 weeks (Study Endpoint)
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
Time frame: Baseline, 2 weeks (Study Endpoint)
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Efficacy Determined Using the Total Severity Scale (TSS) - Adult
Time frame: Baseline, 2 weeks (Study Endpoint)
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.
Efficacy Determined Using the Total Severity Scale (TSS) - Child
Time frame: Baseline, 2 weeks (Study Endpoint)
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.

3 secondary outcomes

Change in Bacterial Composition of Scalp Using RODAC
Time frame: 6 months
Quality of Life Change - Adult
Time frame: Baseline, 2 weeks (Study Endpoint)
Quality of Life Change - Child
Time frame: 1 week (Study midpoint)

Results and safety

Results posted to the registry on 24 Feb 2025, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Intervention Arm	77	77

Primary outcome: Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult

Time frame: Baseline, 2 weeks (Study Endpoint). Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention Arm n = 35
Baseline	2.1 (0.6)
Endpoint	1.1 (0.8)

Intervention Arm: p <0.001, t-test, 1 sided

Primary outcome: Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child

Time frame: Baseline, 2 weeks (Study Endpoint). Mean (95% Confidence Interval). Unit: units on a scale

Measure	Intervention Arm n = 42
Baseline	3.0 (2.8 to 3.3)
Endpoint	2.0 (1.8 to 2.2)

Intervention Arm: p <0.001, t-test, 1 sided

Primary outcome: Efficacy Determined Using the Total Severity Scale (TSS) - Adult

Time frame: Baseline, 2 weeks (Study Endpoint). Mean (Standard Deviation). Unit: units on a scale

Measure	Intervention Arm n = 35
Baseline	3.5 (1.4)
Endpoint	1.8 (1.0)

Intervention Arm: p <0.001, t-test, 1 sided

Primary outcome: Efficacy Determined Using the Total Severity Scale (TSS) - Child

Time frame: Baseline, 2 weeks (Study Endpoint). Mean (95% Confidence Interval). Unit: units on a scale

Measure	Intervention Arm n = 42
Baseline	3.6 (3.1 to 4.2)
Endpoint	1.8 (1.3 to 2.2)

Intervention Arm: p <0.001, t-test, 1 sided

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Data was collected over the course of 14 days. Not all participants began the study on the same day.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Adults	0 of 35 (0%)	0 of 35 (0%)	0 of 35
Children	0 of 42 (0%)	0 of 42 (0%)	0 of 42

Limitations and caveats (from the sponsor): RODAC: Though scalp swabs were collected, no microbiome data were generated as analysis did not occur. Due to budgetary constraints, RODAC plate analysis was not conducted. The study is now closed, and the IRB is being finalized. Thus, no data are available for this outcome. There is no possibility of future analysis. Child SCALPDEX: Statistical analysis could not be performed since endpoint data were not collected. Thus, changes in quality of life for this subgroup could not be analyzed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 24 Feb 2025.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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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. This study is not recruiting at the moment.

Lucy Bilaver, PHD principal investigator

Feinberg School of Medicine- Northwestern

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 1/2 study testing Natural Treatment in people with Dermatitis, Seborrheic and Dry Skin; Eczema, run by Ann & Robert H Lurie Children's Hospital of Chicago at 1 site in United States.

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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Feb 2025. 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 United States. 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.

What does this combined phase mean?

Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 24 Feb 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult (time frame: Baseline, 2 weeks (Study Endpoint)). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03830177.

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 24 Feb 2025.