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| Name | Class |
|---|---|
| Eclipse Aesthetics, LLC | OTHER |
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The purpose of this study is to evaluate the clinical efficacy of platelet rich plasma (PRP) injections for non-scaring alopecia in women. A randomized, placebo-controlled clinical trial will be performed where patients with non-scarring alopecia will either receive injections of their own PRP or injections of normal saline (placebo). Patients in the treatment group (Group A) will have a small amount of their own blood drawn and have their PRP injected into their scalp four times. The injections will be given at weeks zero, four, eight, and twenty four. The placebo group (Group B) will be given the same schedule but will receive sham injections only and will not have any blood drawn. Both groups will have clinical data collected at all visits, including a screening visit before enrollment and a final assessment visit at week 40, for a total of 6 study visits per patient. Data collection will include representative photographs of the scalp and measurements of hair thickness. The results from the two groups will then be compared.
In summary, all study participants will have a screening visit before enrollment, four study visits for sub-dermal scalp injections, and one final assessment visit at week 40.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | 15 participants will receive 3 mL of preservative free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24. |
|
| Treatment | Experimental | 15 participants will receive 3-6 mL of platelet rich plasma injected in a standardized pattern with each injection 1-2 cm apart with 0.2 to 0.3 mL per injection. Participants will receive this treatment at weeks 0, 4, 8, and 24. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Platelet Rich Plasma | Device | Platelet Rich Plasma (PRP) is defined as an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood. Using the Eclipse PRP system, the participants PRP will be attained. The PRP will then be used as described in the arm/group description section. |
| Measure | Description | Time Frame |
|---|---|---|
| Number of Participants With Improvement | Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II | through study completion, 24 weeks |
| Change in Hair Caliber Using Trichoscopy | Change in Hair Caliber using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair caliber in millimeters. | Week 8 and 24 |
| Change in Hair Density Using Trichoscopy | Change in Hair Density using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair density (number of hairs in a square centimeter of scalp). | Week 8 and 24 |
| Measure | Description | Time Frame |
|---|---|---|
| Qualitative Assessment of Hair Growth | Surveys will be distributed to assess participant opinion regarding overall hair growth after treatment. This will be done using a hair growth scale in which 0 is no improvement in hair growth and 10 is greatly improved hair growth. | Week 40 |
| Qualitative Assessment of Pain Associated With the Treatment |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Hooman Khorasani, MD | Icahn School of Medicine at Mount Sinai | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Icahn School of Medicine at Mount Sinai | New York | New York | 10028 | United States |
Raw individual participant data will not be shared with other researchers in an effort to preserve participant confidentiality.
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| ID | Title | Description |
|---|---|---|
| FG000 | Platelet Rich Plasma (PRP) Group | 4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
| FG001 | Placebo Group | 4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Platelet-rich Plasma Group | 4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
| BG001 |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| 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 | Number of Participants With Improvement | Number of participants with improvement by qualitative global assessment of hair growth using photography. Photographs of the scalp with standard digital camera used to assess overall change in hair appearance on a macroscopic level. This will be done using the Ludwig Classification system. I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II | Posted | Count of Participants | Participants | through study completion, 24 weeks |
|
24 weeks
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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 | Platelet-rich Plasma Group | 4.0 mL of Platelet Rich Plasma (PRP), an autologous concentration of human platelets that is 3 to 5 times greater than physiologic concentration of platelets in whole blood, injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
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| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Headache | Nervous system disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Danielle P. Dubin | Icahn School of Medicine at Mount Sinai | 212-731-3311 | DPDubin121@gmail.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| SAP | No | Yes | No | Statistical Analysis Plan | Sep 21, 2018 | Sep 11, 2020 | SAP_001.pdf |
| Prot | Yes | No | No | Study Protocol | Sep 21, 2018 | Sep 11, 2020 | Prot_002.pdf |
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| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |
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|
| Normal saline | Drug | Preservative-free normal saline will be used as described in arm/group description section. |
|
Surveys will be distributed to assess participant opinion regarding the degree of pain associated with the treatment. This will be done using a pain scale of 0 to 10 with 0 being no pain and 10 being worst pain ever. |
| Week 40 |
| Qualitative Assessment of Adverse Effects Associated With the Treatment | Questionnaires will be distributed to assess participant opinion regarding adverse effects associated with the treatment. This will be assessed via a multiple choice questionnaire with the following options: i. Headache ii. Scalp tightness iii. Swelling iv. Redness v. Post-injection bleeding vi. Infection vii. Nerve damage viii. Other: ____________________ ix. None | Week 40 |
| Placebo Group |
4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Hair Loss | Mean | Full Range | months |
|
| Ludwig Score | I is appreciable thinning of the crown hair, II is increased territorial involvement and scalp visibility, and III is total denudation of the areas involved in I and II | Count of Participants | Participants |
|
| Hair Density | Mean | Full Range | hairs/cm^2 |
|
| Hair Caliber | Mean | Full Range | mm |
|
| OG001 | Placebo Group | 4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. |
|
|
| Primary | Change in Hair Caliber Using Trichoscopy | Change in Hair Caliber using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair caliber in millimeters. | Posted | Mean | Standard Deviation | mm | Week 8 and 24 |
|
|
|
| Primary | Change in Hair Density Using Trichoscopy | Change in Hair Density using trichoscopy as compared to baseline. Trichoscopy is a microscope used to assess hair. This was used to measure hair density (number of hairs in a square centimeter of scalp). | Posted | Mean | Standard Deviation | hairs/cm^2 | Week 8 and 24 |
|
|
|
| Secondary | Qualitative Assessment of Hair Growth | Surveys will be distributed to assess participant opinion regarding overall hair growth after treatment. This will be done using a hair growth scale in which 0 is no improvement in hair growth and 10 is greatly improved hair growth. | Data not collected | Posted | Week 40 |
|
|
| Secondary | Qualitative Assessment of Pain Associated With the Treatment | Surveys will be distributed to assess participant opinion regarding the degree of pain associated with the treatment. This will be done using a pain scale of 0 to 10 with 0 being no pain and 10 being worst pain ever. | Data not collected | Posted | Week 40 |
|
|
| Secondary | Qualitative Assessment of Adverse Effects Associated With the Treatment | Questionnaires will be distributed to assess participant opinion regarding adverse effects associated with the treatment. This will be assessed via a multiple choice questionnaire with the following options: i. Headache ii. Scalp tightness iii. Swelling iv. Redness v. Post-injection bleeding vi. Infection vii. Nerve damage viii. Other: ____________________ ix. None | Data not collected at 40 weeks. | Posted | Week 40 |
|
|
| 0 |
| 14 |
| 0 |
| 14 |
| 11 |
| 14 |
| EG001 | Placebo Group | 4.0 mL of Preservative-free normal saline injected in a standardized pattern with each injection 1-2 cm apart with 0.2 mL per injection. | 0 | 14 | 0 | 14 | 6 | 14 |
| Scalp tightness | General disorders | Systematic Assessment |
|
| Swelling | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Redness | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Post-injection bleeding | Blood and lymphatic system disorders | Systematic Assessment |
|
| Tingling | Nervous system disorders | Systematic Assessment |
|
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| D020763 |
| Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |