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

Study Overview
=================
Brief Summary
-----------------
The purpose of this study is to determine if a topical treatment for dry scalp conditions, is safe and effective in clinically improving dry scalp conditions. The investigators will additionally examine individuals experience in using the treatment as well as any changes in the scalp microbiome before and after use studying the treatment , the investigators hope to offer children and adults a new, natural way to improve dry scalp conditions.

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

Conditions
-----------------
Dermatitis, Seborrheic, Dry Skin; Eczema

Intervention / Treatment
-----------------
* Drug: Natural Treatment


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Age 1 year (or corrected age of 1 year, for those born prematurely) to 11 years for children (those who turn 12 over the study period will not be enrolled), and 18 and older Diagnosed with a dry scalp condition with and IGA score of 2 of greater by a board-certified Dermatologist, Allergist, or Pediatrician Good general health Participant and/or their parent are able to read, write, and understand study materials in English Exclusion Criteria: Infants younger than 1 year old and between the ages of 12 and 18 (those who turn 12 over the study period will not be enrolled) 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

Ages Eligible for Study
-----------------
Minimum Age: 1 Year

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
Accepts Healthy Volunteers

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Adults<br>All adults in the study will receive the treatment for dry scalp. | Drug: Natural Treatment<br>* The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days.<br>|
| Experimental: Children<br>All children in the study will receive the treatment for dry scalp. | Drug: Natural Treatment<br>* The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days.<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety/patients comfort of the product using Overall Safety Score assessment, a 4 point assessment. | Safety will be determined by contacting the patient via text over the phone and through a daily journal designed to document adverse events and Overall Safety Score. The Overall Safety Score and the reporting of adverse events throughout the study will measure the safety of the treatment. The Overall Safety Score is a 4-point assessment ranging from no signs of irritation (0) to patient discontinued due to irritation (3). | 6 months | 
| Improvement of patients erythema, scaling, and pruritus | Efficacy will be determined using the Investigator's Global Assessment (IGA) scale, a 5-point assessment ranging from clear (0) to severe disease (4) and the Total Severity Scale (TSS), an assessment that averages erythema, scaling, and pruritus severity scores of scalp lesions. The TSS uses a 4-point scale ranging from none (0) to severe (3). | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in bacterial composition of scalp using RODAC | An exploratory aim of this study is to find whether the natural treatment changes the microbiome after use for a dry scalp condition to more closely resemble healthy scalps. This will be accomplished by obtaining swab samples from the participants' scalps, before and after the treatment period. The samples will be analyzed using 16s RNA sequencing and internal transcribed spacer (ITS) sequencing. Additionally, the change in colony count of bacterial and fungal colonies on the scalp before and after the treatment will be assessed using the Replicate Organism Detection and Counting (RODAC) method. | 6 months | 
| Quality of Life change | Quality of life will be calculated using the ScalpDex tool, a validated 23-item instrument that explains the way that patients with scalp dermatitis are affected by symptoms, functioning, and emotions.The scale is the Scalpdex quality of life instrument and asks questions about everyday activities such as wearing black clothes to itching. For the scale,the higher the score, the worse the outcome for the patient. | 6 months |