Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Enrollment
- 77
- Locations
- 1
- Primary Endpoint
- Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
Study Overview
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.
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.
Study Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 1 Year to — (Child, Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •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
Arms & Interventions
Intervention Arm
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.
Intervention: Natural Treatment (Drug)
Outcomes
Primary Outcomes
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 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 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.
Secondary Outcomes
- 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))