Dermatitis, Seborrheic, Dry Skin; Eczema
Conditions
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.
Interventions
DRUGNatural Treatment
Participants will receive a topical treatment formulated with natural ingredients (Lactobacillus sp., honey, and turmeric) and a kit containing all necessary materials, including an instruction handout. The treatment is applied to the scalp, left for roughly 5 minutes, and rinsed off.
Sponsors
Northwestern University Feinberg School of Medicine
Ann & Robert H Lurie Children's Hospital of Chicago
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
1 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Baseline, 2 weeks (Study Endpoint) | The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity. |
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Baseline, 2 weeks (Study Endpoint) | The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity. |
| Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Baseline, 2 weeks (Study Endpoint) | The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity. |
| Efficacy Determined Using the Total Severity Scale (TSS) - Child | Baseline, 2 weeks (Study Endpoint) | The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quality of Life Change - Adult | Baseline, 2 weeks (Study Endpoint) | Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Assessments were conducted at Baseline and after 2 weeks (Study Endpoint) to measure changes over time. |
| Quality of Life Change - Child | 1 week (Study midpoint) | Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Originally, assessments were to be conducted at baseline and endpoint to measure changes in quality of life. However, for children, only midpoint data were collected, so change could not be measured. |
| Change in Bacterial Composition of Scalp Using RODAC | 6 months | This exploratory outcome assesses whether the topical treatment alters the scalp microbiome to more closely resemble that of a healthy scalp. Scalp samples were collected at baseline and endpoint using swabs and analyzed with 16S ribosomal RNA (rRNA) sequencing for bacterial diversity and internal transcribed spacer (ITS) sequencing for fungal diversity. Colony counts were measured using the Replicate Organism Detection and Counting (RODAC) method to evaluate bacterial and fungal load changes. |
Countries
United States
Participant flow
Pre-assignment details
The protocol initially planned for 80 participants, but 77 were successfully enrolled at baseline across the two groups - child and adult.
Participants by arm
| Arm | Count |
|---|---|
| Intervention Arm All participants receive the topical scalp treatment containing Lactobacillus, honey, and turmeric. Adult participants apply the treatment daily for 14 days, while child participants apply the treatment 2-3 times weekly for 14 days. This arm contains two subgroups for analysis - children and adults. | 77 |
| Total | 77 |
Baseline characteristics
| Characteristic | Intervention Arm |
|---|---|
| Age, Categorical Adults <=18 years | 0 Participants |
| Age, Categorical Adults >=65 years | 0 Participants |
| Age, Categorical Adults Between 18 and 65 years | 35 Participants |
| Age, Categorical Children <=18 years | 42 Participants |
| Age, Categorical Children >=65 years | 0 Participants |
| Age, Categorical Children Between 18 and 65 years | 0 Participants |
| Race (NIH/OMB) Adults American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Adults Asian | 17 Participants |
| Race (NIH/OMB) Adults Black or African American | 2 Participants |
| Race (NIH/OMB) Adults More than one race | 2 Participants |
| Race (NIH/OMB) Adults Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Adults Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) Adults White | 14 Participants |
| Race (NIH/OMB) Children American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Children Asian | 3 Participants |
| Race (NIH/OMB) Children Black or African American | 2 Participants |
| Race (NIH/OMB) Children More than one race | 11 Participants |
| Race (NIH/OMB) Children Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Children Unknown or Not Reported | 6 Participants |
| Race (NIH/OMB) Children White | 20 Participants |
| Region of Enrollment United States | 77 participants |
| Sex: Female, Male Adults Female | 19 Participants |
| Sex: Female, Male Adults Male | 16 Participants |
| Sex: Female, Male Children Female | 27 Participants |
| Sex: Female, Male Children Male | 15 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 35 | 0 / 42 |
| other Total, other adverse events | 0 / 35 | 0 / 42 |
| serious Total, serious adverse events | 0 / 35 | 0 / 42 |
Outcome results
Primary
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Time frame: Baseline, 2 weeks (Study Endpoint)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Baseline | 2.1 units on a scale | Standard Deviation 0.6 |
| Intervention Arm | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Endpoint | 1.1 units on a scale | Standard Deviation 0.8 |
p-value: <0.001t-test, 1 sided
Primary
Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child
The Investigator's Global Assessment (IGA) is a 5-point scale used to evaluate the severity of dry scalp conditions. Scores range from 0 (clear) to 4 (severe disease), based on clinical signs such as flaking, erythema, and pruritus. Assessments were conducted at baseline and endpoint to evaluate the efficacy of the treatment in reducing symptom severity.
Time frame: Baseline, 2 weeks (Study Endpoint)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Arm | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Baseline | 3.0 units on a scale |
| Intervention Arm | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Endpoint | 2.0 units on a scale |
p-value: <0.001t-test, 1 sided
Primary
Efficacy Determined Using the Total Severity Scale (TSS) - Adult
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.
Time frame: Baseline, 2 weeks (Study Endpoint)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Baseline | 3.5 units on a scale | Standard Deviation 1.4 |
| Intervention Arm | Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Endpoint | 1.8 units on a scale | Standard Deviation 1 |
p-value: <0.001t-test, 1 sided
Primary
Efficacy Determined Using the Total Severity Scale (TSS) - Child
The Total Severity Scale (TSS) evaluates the severity of dry scalp conditions by averaging individual scores for erythema, scaling, and pruritus of scalp lesions. Each component is scored on a 4-point scale, ranging from 0 (none) to 3 (severe). The TSS is calculated by summing the scores of individual subscales, each representing a key symptom or feature of the condition, for a total possible score range of 0 to 9, with higher scores indicating greater severity. TSS assessments were conducted at baseline and 2 weeks (Study Endpoint) to determine the treatment's efficacy in reducing symptom severity.
Time frame: Baseline, 2 weeks (Study Endpoint)
| Arm | Measure | Group | Value (MEAN) |
|---|---|---|---|
| Intervention Arm | Efficacy Determined Using the Total Severity Scale (TSS) - Child | Baseline | 3.6 units on a scale |
| Intervention Arm | Efficacy Determined Using the Total Severity Scale (TSS) - Child | Endpoint | 1.8 units on a scale |
p-value: <0.001t-test, 1 sided
Secondary
Change in Bacterial Composition of Scalp Using RODAC
This exploratory outcome assesses whether the topical treatment alters the scalp microbiome to more closely resemble that of a healthy scalp. Scalp samples were collected at baseline and endpoint using swabs and analyzed with 16S ribosomal RNA (rRNA) sequencing for bacterial diversity and internal transcribed spacer (ITS) sequencing for fungal diversity. Colony counts were measured using the Replicate Organism Detection and Counting (RODAC) method to evaluate bacterial and fungal load changes.
Time frame: 6 months
Population: Although microbiome samples were collected, no laboratory analysis was conducted, and no data were generated for this outcome measure. As a result, there are no available results to report. There is absolutely no possibility of future analysis.
Secondary
Quality of Life Change - Adult
Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Assessments were conducted at Baseline and after 2 weeks (Study Endpoint) to measure changes over time.
Time frame: Baseline, 2 weeks (Study Endpoint)
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Intervention Arm | Quality of Life Change - Adult | Baseline | 46 units on a scale | Standard Deviation 13.4 |
| Intervention Arm | Quality of Life Change - Adult | Endpoint | 39.5 units on a scale | Standard Deviation 10.3 |
p-value: <0.001t-test, 1 sided
Secondary
Quality of Life Change - Child
Quality of life was assessed using the ScalpDex-23, a validated 23-item instrument designed to evaluate the impact of scalp dermatitis on symptoms, functioning, and emotions. Each item is scored on a 5-point Likert-type scale ('Never' = 0, 'Rarely' = 25, 'Sometimes' = 50, 'Often' = 75, 'All the time' = 100), with higher scores indicating greater impairment. Subscale scores were calculated for Symptoms (7 items), Emotion (8 items), and Functioning (8 items) by averaging the respective item scores. The total ScalpDex-23 score was calculated as the average of the three subscale scores, yielding a final value ranging from 0 to 100. Originally, assessments were to be conducted at baseline and endpoint to measure changes in quality of life. However, for children, only midpoint data were collected, so change could not be measured.
Time frame: 1 week (Study midpoint)
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Intervention Arm | Quality of Life Change - Child | 44.2 units on a scale | Standard Deviation 21.1 |