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

NCT03830177 | Completed Phase 1 Results FDA Drug

• 1 other identifier: 2019-2309
• Study Type: interventional
• Target: 77
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Dermatitis, Seborrheic; Dry Skin; Eczema

Outcome Measures

Primary Outcomes (4)

• 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.

  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.

  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.

  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.

  Baseline, 2 weeks (Study Endpoint)

Secondary Outcomes (3)

• Change in Bacterial Composition of Scalp Using RODAC

  6 months

• Quality of Life Change - Adult

  Baseline, 2 weeks (Study Endpoint)

• Quality of Life Change - Child

  1 week (Study midpoint)

Study Arms (1)

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.

Drug: Natural Treatment

Interventions

Natural Treatment DRUG

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.

Also known as: Yobee

Intervention Arm

Eligibility Criteria

• Age: 1 Year+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Ann & Robert H Lurie Children's Hospital of Chicago: lead
• Northwestern University Feinberg School of Medicine: collaborator

Study Sites (1)

Medical Dermatology Associates of Chicago

Chicago, Illinois, 60654, United States

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic; Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

Limitations and Caveats

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.

Results Point of Contact

• Title: Lucy Bilaver, PhD
• Organization: Northwestern University

l-bilaver@northwestern.edu

312-503-5618

Study Officials

• Lucy Bilaver, PHD

  Feinberg School of Medicine- Northwestern

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 27, 2018
• First Posted: February 5, 2019
• Study Start: July 8, 2019
• Primary Completion: January 11, 2023
• Study Completion: October 4, 2023
• Last Updated: February 24, 2025
• Results First Posted: February 24, 2025

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)