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| Name | Class |
|---|---|
| Northwestern University | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention Arm | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Natural Treatment | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Baseline, 2 weeks (Study Endpoint) |
| 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. | Baseline, 2 weeks (Study Endpoint) |
| 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. | Baseline, 2 weeks (Study Endpoint) |
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Lucy Bilaver, PHD | Feinberg School of Medicine- Northwestern | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Medical Dermatology Associates of Chicago | Chicago | Illinois | 60654 | United States |
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The protocol initially planned for 80 participants, but 77 were successfully enrolled at baseline across the two groups - child and adult.
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| ID | Title | Description |
|---|---|---|
| FG000 | Intervention Arm | The intervention arm includes two subgroups - adults and children. 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | The number analyzed in the row refers specifically to the subgroup in the row title. 35 adult samples were analyzed. 42 child samples were analyzed. Combined, 77 samples were analyzed. |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks (Study Endpoint) |
|
Data was collected over the course of 14 days. Not all participants began the study on the same day.
No difference in definitions.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Adults | All adults in the study will receive the treatment for dry scalp. Natural Treatment: The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days. |
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RODAC: Though scalp swabs were collected, no microbiome data were generated as analysis did not occur. Due to budgetary constraints, RODAC plate analysis was not conducted. The study is now closed, and the IRB is being finalized. Thus, no data are available for this outcome. There is no possibility of future analysis.
Child SCALPDEX: Statistical analysis could not be performed since endpoint data were not collected. Thus, changes in quality of life for this subgroup could not be analyzed.
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lucy Bilaver, PhD | Northwestern University | 312-503-5618 | l-bilaver@northwestern.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Mar 10, 2023 | Dec 5, 2024 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D012628 | Dermatitis, Seborrheic |
| D004485 | Eczema |
| ID | Term |
|---|---|
| D003872 | Dermatitis |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
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|
|
| Baseline, 2 weeks (Study Endpoint) |
| 6 months |
| 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. | Baseline, 2 weeks (Study Endpoint) |
| 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. | 1 week (Study midpoint) |
| Count of Participants |
| Participants |
|
| Sex: Female, Male | The number analyzed in the row refers specifically to the subgroup in the row title. 35 adult samples were analyzed. 42 child samples were analyzed. Combined, 77 samples were analyzed. | Count of Participants | Participants |
|
| Race (NIH/OMB) | The number analyzed in the row refers specifically to the subgroup in the row title. 35 adult samples were analyzed. 42 child samples were analyzed. Combined, 77 samples were analyzed. | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Units |
|---|
| Counts |
|---|
| Participants |
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 2 weeks (Study Endpoint) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks (Study Endpoint) |
|
|
|
|
| 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. | Posted | Mean | 95% Confidence Interval | units on a scale | Baseline, 2 weeks (Study Endpoint) |
|
|
|
|
| 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. | 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. | Posted | 6 months |
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | Baseline, 2 weeks (Study Endpoint) |
|
|
|
|
| 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. | Posted | Mean | Standard Deviation | units on a scale | 1 week (Study midpoint) |
|
|
|
| 0 |
| 35 |
| 0 |
| 35 |
| 0 |
| 35 |
| EG001 | Children | All children in the study will receive the treatment for dry scalp. Natural Treatment: The participant will be given the treatment, which contains all natural ingredients, and a kit of all necessary materials to take home with them, which will include a set of instructions. The kit will contain the instruction handout and their treatment. They will be instructed to apply the treatment to their scalp, wait seven minutes, and then rinse their scalp. They will perform this entire procedure once per day for 14 days. | 0 | 42 | 0 | 42 | 0 | 42 |
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| D017443 |
| Skin Diseases, Eczematous |
| D017444 | Skin Diseases, Papulosquamous |
|
| Black or African American |
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| White |
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| More than one race |
|
| Unknown or Not Reported |
|