Trial · NCT03830177
Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
NCT03830177, Phase 1, Phase 2, Completed, Ann & Robert H Lurie Children's Hospital of Chicago; results first posted 2025-02-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult. Trials, record NCT03830177. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03830177
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Safety and Efficacy of a Topical Scalp Treatment for Dry Scalp Conditions in Children and Adult
- NCT number
- NCT03830177
- Status
- Completed
- Phases
- Phase 1, Phase 2
- Enrollment
- 77 participants, actual
- Lead sponsor
- Ann & Robert H Lurie Children's Hospital of Chicago
- Conditions
- Dermatitis, Seborrheic, Dry Skin; Eczema
- Interventions
- Natural Treatment
- First posted
- 2019-02-05
- Last updated
- 2025-02-24
- Results first posted
- 2025-02-24
- Limitations and caveats
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.
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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. |
| Primary | 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. |
| Primary | 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. |
| Primary | 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 | 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. |
| Secondary | 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. |
| Secondary | 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. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Baseline, 2 weeks (Study Endpoint) | units on a scale | MEAN | |
| PRIMARY | Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Baseline, 2 weeks (Study Endpoint) | units on a scale | MEAN | |
| PRIMARY | Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Baseline, 2 weeks (Study Endpoint) | units on a scale | MEAN | |
| PRIMARY | Efficacy Determined Using the Total Severity Scale (TSS) - Child | Baseline, 2 weeks (Study Endpoint) | units on a scale | MEAN | |
| SECONDARY | Change in Bacterial Composition of Scalp Using RODAC | 6 months | 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 | Baseline, 2 weeks (Study Endpoint) | units on a scale | MEAN | |
| SECONDARY | Quality of Life Change - Child | 1 week (Study midpoint) | units on a scale | MEAN |
Source ClinicalTrials.gov
Results by group11
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Intervention Arm | Baseline | 2.1 | Standard Deviation 0.6 | units on a scale |
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Adult | Intervention Arm | Endpoint | 1.1 | Standard Deviation 0.8 | units on a scale |
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Intervention Arm | Baseline | 3.0 | 95% Confidence Interval 2.8 to 3.3 | units on a scale |
| Efficacy Determined Using the Investigator's Global Assessment (IGA) - Child | Intervention Arm | Endpoint | 2.0 | 95% Confidence Interval 1.8 to 2.2 | units on a scale |
| Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Intervention Arm | Baseline | 3.5 | Standard Deviation 1.4 | units on a scale |
| Efficacy Determined Using the Total Severity Scale (TSS) - Adult | Intervention Arm | Endpoint | 1.8 | Standard Deviation 1.0 | units on a scale |
| Efficacy Determined Using the Total Severity Scale (TSS) - Child | Intervention Arm | Baseline | 3.6 | 95% Confidence Interval 3.1 to 4.2 | units on a scale |
| Efficacy Determined Using the Total Severity Scale (TSS) - Child | Intervention Arm | Endpoint | 1.8 | 95% Confidence Interval 1.3 to 2.2 | units on a scale |
| Quality of Life Change - Adult | Intervention Arm | Baseline | 46 | Standard Deviation 13.4 | units on a scale |
| Quality of Life Change - Adult | Intervention Arm | Endpoint | 39.5 | Standard Deviation 10.3 | units on a scale |
1 to 10 of 11Source ClinicalTrials.gov
See all 11 results by groupParticipant flow5
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Intervention Arm | 77 | |
| Overall Study | Adult | Intervention Arm | 35 | |
| Overall Study | Child | Intervention Arm | 42 | |
| Overall Study | COMPLETED | Intervention Arm | 77 | |
| Overall Study | NOT COMPLETED | Intervention Arm | 0 |
Source ClinicalTrials.gov
Adverse events0
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
None in this release.
Adverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Adults | 0 | 35 |
| Total, all-cause mortality | Children | 0 | 42 |
| Total, other adverse events | Adults | 0 | 35 |
| Total, other adverse events | Children | 0 | 42 |
| Total, serious adverse events | Adults | 0 | 35 |
| Total, serious adverse events | Children | 0 | 42 |
Source ClinicalTrials.gov
Papers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons2
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Adults vs Children: deaths from any cause | Trial comparisons |
| Adults vs Children: serious adverse events | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT03830177
GET https://conductscience.org/api/trials/v1/NCT03830177/registered