Phase 2
N=77
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
Dermatitis, Seborrheic · Dry Skin; Eczema
Bottom Line
View on ClinicalTrials.gov: NCT03830177 ↗Enrolled (actual)
77
Serious AEs
0.0%
Results posted
Feb 2025
Primary outcome: Primary: Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult — 2.1; 1.1 units on a scale — p=<0.001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Natural Treatment (Drug)
- Age
- Pediatric, Adult, Older Adult · 1+ yrs
- Sex
- All
- Sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Primary completion
- Jan 2023
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult |
2.1; 1.1 | <0.001 sig |
| PRIMARY Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child |
3.0; 2.0 | <0.001 sig |
| PRIMARY Efficacy Determined Using the Total Severity Scale (TSS) - Adult |
3.5; 1.8 | <0.001 sig |
| PRIMARY Efficacy Determined Using the Total Severity Scale (TSS) - Child |
3.6; 1.8 | <0.001 sig |
| SECONDARY Change in Bacterial Composition of Scalp Using RODAC |
— | — |
| SECONDARY Quality of Life Change - Adult |
46; 39.5 | <0.001 sig |
| SECONDARY Quality of Life Change - Child |
44.2 | — |
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.
Eligibility Criteria
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
Data sourced from ClinicalTrials.gov (NCT03830177). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.