- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03830177
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
August 6, 2021 updated by: Ann & Robert H Lurie Children's Hospital of Chicago
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adults
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.
Study Overview
Status
Recruiting
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
60
Phase
- Phase 2
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Jennifer R Long
- Phone Number: 6306641231
- Email: jennifer.long@northwestern.edu
Study Contact Backup
- Name: Ruchi Gupta, MD, MPH
- Phone Number: 3125233533
- Email: r-gupta@northwestern.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60654
- Recruiting
- Medical Dermatology Associates of Chicago
-
Contact:
- Peter Lio, MD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
1 year and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Adults
All adults in the study will receive the treatment for dry scalp.
|
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.
|
Experimental: Children
All children in the study will receive the treatment for dry scalp.
|
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.
|
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.
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
Time Frame: 6 months
|
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
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Collaborators
Investigators
- Principal Investigator: Lucy Bilaver, PHD, Feinberg School of Medicine- Northwestern
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 6, 2019
Primary Completion (Anticipated)
August 1, 2022
Study Completion (Anticipated)
August 1, 2022
Study Registration Dates
First Submitted
November 27, 2018
First Submitted That Met QC Criteria
February 1, 2019
First Posted (Actual)
February 5, 2019
Study Record Updates
Last Update Posted (Actual)
August 10, 2021
Last Update Submitted That Met QC Criteria
August 6, 2021
Last Verified
August 1, 2021
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 2019-2309
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
UNDECIDED
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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