Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Jacksonville Center For Clinical Research | OTHER |
| St. Johns Center for Clinical Research | UNKNOWN |
| Fleming Island Center for Clinical Research | UNKNOWN |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
This is a 12 week, multi-site, double-blind, vehicle-controlled study in subjects with mild to moderate facial acne. Subjects will be randomized 1:1 to apply either topical NAG or vehicle gel daily. Subjects will be evaluated for clinical acne and quality of life outcomes at baseline, 2 weeks, 4 weeks, 8 weeks and 12 weeks.
Sample Size: N= 60 completed subjects Male and female subjects 12 years or older diagnosed with mild to moderate inflammatory facial acne vulgaris.
Subjects will be treated with once daily topical NAG or matching vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
Subjects will discontinue all baseline topical acne treatments with a 2 week washout and/or all systemic acne treatments with a 3 week washout. All subjects will be provided open label Cetaphil facial cleanser and double-blind NAG or vehicle product.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Vehicle | Placebo Comparator | Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
|
|
| NAG (Next Science Acne Gel) | Active Comparator | Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Next Science Acne Gel | Drug | Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use. | Baseline until 12 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment | 12 weeks |
| Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives. |
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Susan Greco, MD | Jacksonville Center For Clinical Research | Study Director |
| Annabelle Matias, MD | Fleming Island Center for Clinical Research | Principal Investigator |
| Lara Church, MD | St John's Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Fleming Island Center for Clinical Research | Jacksonville | Florida | 32203 | United States | ||
| Jacksonville Center for Clinical Research |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27272073 | Result | Bernhardt MJ, Myntti MF. Topical Treatment With an Agent Disruptive to <em>P. acnes</em> Biofilm Provides Positive Therapeutic Response: Results of a Randomized Clinical Trial. J Drugs Dermatol. 2016 Jun 1;15(6):677-83. |
Not provided
Not provided
Subjects were enrolled in the study after signing informed consent and meeting inclusion/exclusion criteria per protocol. A Washout period of 2-3 weeks was initiated for subjects discontinuing topical acne or systemic acne treatment respectively to normalize by washing their face twice a day with the study facial cleansing soap.
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | Vehicle | Subjects will be treated with once daily vehicle and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
Vehicle: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel. |
| FG001 | NAG (Next Science Acne Gel) | Subjects will be treated with once daily NAG and will attend screening, randomization, 2,4,8 and 12 week visits. The following will be assessed:
Next Science Acne Gel: Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | Vehicle | Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| 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 | Change in Inflammatory Lesions With Daily Use of NAG Compared With Vehicle After 12-weeks of Use. | Percent change in number of Inflammatory lesions with daily use of NAG compared with vehicle after 12-weeks of use. | Subjects who completes all visits. | Posted | Mean | Standard Error | % change of inflammatory lesions count | Baseline until 12 weeks |
|
12 Weeks.
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Vehicle | Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
Vehicle: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. |
Not provided
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Bronchitis | Infections and infestations | Systematic Assessment |
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Matt Myntti PHD, President | Next Science | 9046474161 | mmyntti@nextscience.org |
Not provided
| ID | Term |
|---|---|
| D000152 | Acne Vulgaris |
| ID | Term |
|---|---|
| D017486 | Acneiform Eruptions |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D012625 | Sebaceous Gland Diseases |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
| Vehicle | Drug | Subjects will be instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should not be applied around the eyes or near the mucous membranes. No other acne treatments will be applied to the face during study participation. Hands should be washed following application of study gel. |
|
Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0). |
| Baseline until 12 weeks |
| Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | Baseline until 12 weeks |
| Baseline until 12 weeks |
| Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | Baseline until 12 weeks |
| Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | Baseline until 12 weeks |
| Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | Baseline until 12 weeks |
| Jacksonville |
| Florida |
| 32216 |
| United States |
| St. Johns Center for Clinical Research | Ponte Vedra | Florida | 32081 | United States |
| BG001 | NAG (Next Science Acne Gel) | Subjects were treated with once daily vehicle and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. Product should was not to be applied around the eyes or near the mucous membranes. No other acne treatments was applied to the face during study participation. |
| BG002 | Total | Total of all reporting groups |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Count of Participants | Participants |
|
|
|
|
| Secondary | Percent Change in Non-Inflammatory Lesion Counts After 12 Weeks of Treatment. | Percent Change in Number of Non-inflammatory lesions (open and closed comedones) were counted after 12 weeks of either Vehicle of NAG treatment | Posted | Mean | Standard Deviation | % Change Non-inflammatory lesion count | 12 weeks |
|
|
|
| Secondary | Final Investigator Global Assessment Score With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Investigator Global Assessment (IGA) score (0-5) with daily use of NAG compared with vehicle after 12-weeks. IGA score is worse at 5, with improvement at lower scores (best at 0). | Posted | Mean | Standard Error | Score on a scale | Baseline until 12 weeks |
|
|
|
|
| Secondary | Change in Erythema Scores With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Erythema (measure of redness) scores with daily use of NAG compared with vehicle after 12-weeks.Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | The Next Science Acne Gel had average erythema score decreasing from 0.5 to 0.3 for the Acne Gel and to 0.5 to 0.4 for the Vehicle Control (not shown). | Posted | Mean | Standard Deviation | Average Score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Dryness With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Dryness score with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG application yielded Dryness average scores decreasing from 0.3 to 0.1 over 12 weeks compared to no decrease in the Vehicle control (0.3 to 0.3). | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Burning/Stinging With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Burning/Stinging scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG application resulted in average Burning or Stinging scores increasing from 0.0 to 0.1 over 12 weeks, compared to a decrease in Vehicle Control from 0.1 to 0.0. | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Erosion With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Erosion scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG application resulted in average scores remaining between 0.1 and 0.0 for all time points for both NAG and Vehicle groups. | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Edema With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Edema scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG application resulted in average scores decreasing from 0.1 to 0.0 for the Acne Gel, and from 0.2 to 0.1 for the Vehicle Control. | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Pain With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Pain scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG and vehicle application yielded average pain scores decreasing from 0.1 to 0.0. | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Secondary | Change in Itching With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Itching scores with daily use of NAG compared with vehicle after 12-weeks. Treatment area evaluation scoring system ranges from 0-3, with 0 being Absent (none) and 3 being Severe (intense, marked presence). | NAG application resulted in Itching scores of 0.1 to 0.0 for the Acne Gel and from 0.2 to 0.0 for the Vehicle Control. | Posted | Mean | Standard Deviation | Average score on a scale | Baseline until 12 weeks |
|
|
|
| Other Pre-specified | Change in Quality of Life - Self Perception With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Self Perception scores with daily use of NAG compared with vehicle after 12-weeks. The Acne Quality of Life (QoL) Questionnaire Form was used to determine the practical improvements in quality of life. The Acne-QoL form is a validated measure that contains 19 questions referring to the past week, organized into four area: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives. | The average self-perception score for NAG users increased from 4.1 to 5.0. | Posted | Mean | Standard Deviation | Score on a scale | Baseline until 12 weeks |
|
|
|
| Other Pre-specified | Change in Quality of Life - Role Emotional With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in Role-Emotional scores with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | Posted | Mean | Standard Deviation | Score on a scale | Baseline until 12 weeks |
|
|
|
| Other Pre-specified | Change in Quality of Life - Perceived Acne Symptoms With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in the subjects perception of their acne symptoms with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | Posted | Mean | Standard Deviation | Score on a scale | Baseline until 12 weeks |
|
|
|
| Other Pre-specified | Change in Quality of Life - Role Social With Daily Use of NAG Compared With Vehicle After 12-weeks. | Change in subjects social response to their acne with daily use of NAG compared with vehicle after 12-weeks. At baseline and each subsequent visit, subjects completed the Acne-QoL form after being given verbal instructions by the study coordinator. The Acne QoL is a validated measure that contains 19 questions referring to the past week, organized into four areas: self-perception, role-social, role-emotional, and acne symptoms. Each question gauges how much acne affects the subject, with answers ranging from 0 (extremely) to 6 (not at all). Domain scores are calculated by taking the average scores within each domain, with high scores reflecting better QoL determination. The number of subjects with a negative score for each quality of life region was determined at each time-point. Those with a negative score, were those with a score of 3.5 or less, indicating that the disease was having a meaningful effect on their lives | The average Role-Social score increased from 4.5 to 5.3. | Posted | Mean | Standard Deviation | Score on a scale | Baseline until 12 weeks |
|
|
|
| 0 |
| 33 |
| 0 |
| 33 |
| 7 |
| 33 |
| EG001 | NAG (Next Science Acne Gel) | Subjects were treated with once daily NAG and attended screening, randomization, 2,4,8 and 12 week visits. The following was assessed:
Next Science Acne Gel: Subjects were instructed to apply a thin layer of the product to the entire face every evening after washing with Cetaphil cleanser and gently patting the skin dry. | 0 | 35 | 0 | 35 | 9 | 35 |
| Gastritis | General disorders | Systematic Assessment |
|
| Vomiting | General disorders | Systematic Assessment | Vomiting |
|
| Haemtoma | Infections and infestations | Systematic Assessment | Left Thumbnail Haematoma |
|
| Rhinitis | Infections and infestations | Systematic Assessment |
|
| Urinary Tract Infection | Infections and infestations | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| General aches | General disorders | Systematic Assessment |
|
| Mild celiac disease | General disorders | Systematic Assessment |
|
| Abdominal cramps | General disorders | Systematic Assessment |
|
| Laryngitis | Infections and infestations | Systematic Assessment |
|
| Cough | Infections and infestations | Systematic Assessment |
|
| Upper Respiratory Infection | Infections and infestations | Systematic Assessment |
|
| Otitis Media | Infections and infestations | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
Not provided
Not provided