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

Primary Purpose

Dermatitis, Seborrheic, Dry Skin; Eczema

Status
Unknown status
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Natural Treatment
Sponsored by
Ann & Robert H Lurie Children's Hospital of Chicago
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Dermatitis, Seborrheic

Eligibility Criteria

1 Year - undefined (Child, Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  1. 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
  2. Diagnosed with a dry scalp condition with and IGA score of 2 of greater by a board-certified Dermatologist, Allergist, or Pediatrician
  3. Good general health
  4. Participant and/or their parent are able to read, write, and understand study materials in English

Exclusion Criteria:

  1. 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)
  2. Patients diagnosed with other scalp diseases such as psoriasis, tinea capitis, and pediculosis capitis
  3. Systemic steroid or oral antibiotic use during the past two months
  4. Allergy to any of the preparation components

Sites / Locations

  • Medical Dermatology Associates of ChicagoRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Adults

Children

Arm Description

All adults in the study will receive the treatment for dry scalp.

All children in the study will receive the treatment for dry scalp.

Outcomes

Primary Outcome Measures

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).
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).

Secondary Outcome Measures

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.
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.

Full Information

First Posted
November 27, 2018
Last Updated
August 6, 2021
Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Northwestern University Feinberg School of Medicine
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1. Study Identification

Unique Protocol Identification Number
NCT03830177
Brief Title
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
Official Title
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Unknown status
Study Start Date
May 6, 2019 (Actual)
Primary Completion Date
August 1, 2022 (Anticipated)
Study Completion Date
August 1, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ann & Robert H Lurie Children's Hospital of Chicago
Collaborators
Northwestern University Feinberg School of Medicine

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dermatitis, Seborrheic, Dry Skin; Eczema

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Adults
Arm Type
Experimental
Arm Description
All adults in the study will receive the treatment for dry scalp.
Arm Title
Children
Arm Type
Experimental
Arm Description
All children in the study will receive the treatment for dry scalp.
Intervention Type
Drug
Intervention Name(s)
Natural Treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
Safety/patients comfort of the product using Overall Safety Score assessment, a 4 point assessment.
Description
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).
Time Frame
6 months
Title
Improvement of patients erythema, scaling, and pruritus
Description
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).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in bacterial composition of scalp using RODAC
Description
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.
Time Frame
6 months
Title
Quality of Life change
Description
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.
Time Frame
6 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
1 Year
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jennifer R Long
Phone
6306641231
Email
jennifer.long@northwestern.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Ruchi Gupta, MD, MPH
Phone
3125233533
Email
r-gupta@northwestern.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucy Bilaver, PHD
Organizational Affiliation
Feinberg School of Medicine- Northwestern
Official's Role
Principal Investigator
Facility Information:
Facility Name
Medical Dermatology Associates of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60654
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Peter Lio, MD

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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

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