NCT03830177

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

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

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 77 (actual)
• Sponsor: Ann & Robert H Lurie Children's Hospital of Chicago · Academic / Other
• Sex: All
• Age: 1 Year
• Healthy volunteers: Accepted

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.

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

Interventions

Type	Name	Description
DRUG	Natural Treatment	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.

Timeline

• Start date: 2019-07-08
• Primary completion: 2023-01-11
• Completion: 2023-10-04
• First posted: 2019-02-05
• Last updated: 2025-02-24
• Results posted: 2025-02-24

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study