Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult (NCT03830177) | Clinical Trial Compass
CompletedPhase 1/2
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
United States77 participantsStarted 2019-07-08
Plain-language 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.
Who can participate
Age range
1 Year
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult
Timeframe: Baseline, 2 weeks (Study Endpoint)
2
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
Timeframe: Baseline, 2 weeks (Study Endpoint)
3
Efficacy Determined Using the Total Severity Scale (TSS) - Adult
Timeframe: Baseline, 2 weeks (Study Endpoint)
4
Efficacy Determined Using the Total Severity Scale (TSS) - Child
Timeframe: Baseline, 2 weeks (Study Endpoint)
Trial details
NCT IDNCT03830177
SponsorAnn & Robert H Lurie Children's Hospital of Chicago