Clinical trial NCT03830177: 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
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Dermatitis, Seborrheic
Dry Skin; Eczema
Lead sponsor: Ann & Robert H Lurie Children's Hospital of Chicago
Sponsor class: OTHER
Collaborators: name: Northwestern University Feinberg School of Medicine
First posted: 2019-02-05
Enrollment: 77
Sex: ALL
Minimum age (years): 1
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed description: This study evaluates the safety and efficacy of a novel topical scalp treatment for dry scalp conditions, including dandruff, seborrheic dermatitis, and atopic dermatitis. The treatment contains Lactobacillus sp., honey, and turmeric in an emollient base, hypothesized to alleviate symptoms by addressing microbial imbalances, reducing inflammation, and promoting scalp hydration.

The study will enroll 15-40 pediatric participants aged 1-17 years and 20-40 adults aged 18 and older, all clinically diagnosed with dry scalp. All participants will apply the treatment over a 14-day period. Adults will use the treatment daily, while pediatric participants will apply it 2-3 times weekly. Other scalp therapies will be discontinued during the study period.

The study aims to explore the treatment's potential to improve clinical severity, enhance quality of life, and positively impact the scalp microbiome, providing a natural, effective option for managing dry scalp conditions.

Eligibility criteria: Inclusion Criteria:

1. Age 1 year (or corrected age of 1 year, for those born prematurely) to 17 years for children, and adults 18 and older
2. Patients with dry scalp and dandruff symptoms as determined by a board-certified Dermatologist, Allergist, or Pediatrician
3. Good general health
4. Participant and/or their parents are able to read, write, and understand study materials in English

Exclusion Criteria:

1. Infants younger than 1 year old
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

Primary outcomes:
measure: Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult
timeFrame: Baseline, 2 weeks (Study Endpoint)
measure: Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
timeFrame: Baseline, 2 weeks (Study Endpoint)
measure: Efficacy Determined Using the Total Severity Scale (TSS) - Adult
timeFrame: Baseline, 2 weeks (Study Endpoint)
measure: Efficacy Determined Using the Total Severity Scale (TSS) - Child
timeFrame: Baseline, 2 weeks (Study Endpoint)
Secondary outcomes:
measure: Change in Bacterial Composition of Scalp Using RODAC
timeFrame: 6 months
measure: Quality of Life Change - Adult
timeFrame: Baseline, 2 weeks (Study Endpoint)
measure: Quality of Life Change - Child
timeFrame: 1 week (Study midpoint)
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Medical Dermatology Associates of Chicago
state: Illinois
Study officials:
affiliation: Feinberg School of Medicine- Northwestern
name: Lucy Bilaver, PHD
role: PRINCIPAL_INVESTIGATOR
References: