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

Ann & Robert H Lurie Children's Hospital of Chicago

Status and phase: Completed; Phase 2; Phase 1

Conditions: Dermatitis, Seborrheic; Dry Skin; Eczema

Treatments: Drug: Natural Treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT03830177

2019-2309

Details and patient eligibility

About

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.

Full 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.

Enrollment: 77 patients

Sex: All

Ages: 1+ year old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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77 participants in 1 patient group

Intervention Arm

Experimental group

Description:

All participants receive a topical scalp treatment containing Lactobacillus sp., honey, and turmeric. Adults apply the treatment daily for 14 days, while children apply it 2-3 times weekly for 14 days.

Treatment:

Drug: Natural Treatment