Baldness/Hair Restoration

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Baldness/Hair Restoration

General Purpose:

Hair loss is commonly associated with baldness in men, however it is important to understand that it can affect both men and women, and can affect other areas of the body in addition to the scalp. Hair loss can occur as a result of hereditary factors, but can also occur as a side effect of certain medications or medical conditions. Anyone, regardless of age, sex, race, or ethnicity, can experience hair loss.

Hair loss from the scalp, or baldness, is addressed differently by different individuals. Some prefer to let their hair loss progress naturally and uninterrupted, and make no efforts to conceal it. Others prefer to use hairstyles, wigs, or accessories (such as a hat) to minimize the appearance of their baldness.

For some individuals, hair loss can be a source of emotional distress and/or an aesthetic concern, and as a result, they choose to pursue treatment to slow down or restore their hair loss.

If hair loss is negatively affecting your life, there are clinical trials available that may be able to help you. Some research is aimed at minimizing hair loss as a side effect of various medications and therapies, while others studies are working to develop new and more effective ways to slow its progression.

What Will Hair Loss Clinical Trials Be Like?

The types of procedures used in hair loss clinical trials will ultimately depend on the specific nature of the study and what aspect of hair loss is being studied. Provided below is a list of common procedures, tests, and assessments that may be incorporated into such clinical trials:

  • Detailed physical examination
  • A questionnaire or face-to-face interview to provide details related to your history of hair loss, which may include questions related to the following:
    • Date you first noticed your hair loss or thinning
    • Use of cosmetic and personal hygiene products
    • Family history of hair loss
    • Use of prescription or over-the-counter medications, including vitamins, minerals, and other dietary supplements.
    • Treatments you have attempted to use for your hair loss.
    • You may also be asked to use a specific shampoo and/or conditioner during the course of the study, or you may be asked to refrain from washing your hair or scalp.
    • Questionnaires to evaluate your stress level and/or emotional well-being.
    • Blood tests
    • Scalp or skin biopsy, depending on the location of your hair loss.
    • You may be asked to provide a hair sample for analysis.
    • Detailed examination and mapping of your scalp or other areas of hair loss.
    • Dietary logs
    • Photographs of your scalp or other areas of hair loss.
    • Use of lotions, creams, oral medications, or laser light therapy.

Typical Hair Loss Clinical Trial Protocol:

Specific examples of clinical trials for hair loss might include the following:

  • A clinical trial in which a newly-developed topical medication is applied to one-half of the scalp of individuals suffering from hair loss for a six month period. During this trial, individuals would be assessed at regular four week intervals to observe and document any new hair growth in previously-bald areas. Treating only one-half of the scalp allows the untreated half of the scalp to serve as a control.
  • A study in which women who have previously been treated for breast cancer with the chemotherapy drug docetaxel wear a special cap designed to provide a cooling effect on the scalp. The purpose of this study would be to determine if the use of such a cooling cap is safe and effective at preventing or minimizing hair loss associated with this particular chemotherapy regimen.
  • A study in which individuals who are experiencing significant hair loss due to a particular disease provide hair samples for analysis. The hair samples are then analyzed to determine the presence of a pre-defined set of vitamins and minerals. Based on each individual’s hair analysis, they are then prescribed a personalized diet and supplement regimen for a six month period. The purpose of this study would be to determine if personalized dietary modifications based on hair analysis are effective at slowing the progression of hair loss in patients with this particular disease.
  • A randomized clinical trial in which individuals with total-body hair loss are randomly assigned to receive either a newly developed drug designed to stimulate hair growth or a placebo.

A brief word about randomized trials and placebos: 

Many clinical trials involve the comparison of an investigational treatment to a “standard” treatment. Some studies determine which therapy a patient receives through a process known as randomization, in which patients are randomly assigned to receive either the investigational treatment or the standard treatment.

On occasion, a trial will investigate the use of a standard treatment plus a new drug compared to standard treatment plus a placebo. Placebos are inactive or “sham” treatments that are identical in appearance to the active treatment but have no therapeutic value.

Placebos are necessary to help determine if adverse effects that occur during the clinical trial are the result of the investigational treatment or due to some other factor. They also allow researchers to measure the effects of the active treatment and observe what would have happened without it.

In rare instances where no standard therapy exists, or when a new drug or therapy is being investigated, the investigational treatment might be compared to a placebo alone (such as the fourth clinical trial example described above). In these types of trials, those patients who are randomized to the placebo group do not receive an active treatment.

It is important to know that placebo-only trials are only conducted when scientifically necessary and when patients have been adequately informed that they may end up receiving the placebo rather than the active treatment. It is very important to note, however, that no one should ever participate in such a placebo trial when there is a widely available and highly effective standard treatment already in existence for their particular disease or condition.

Trial Eligibility and Medical Information Needed:

The type of clinical trial you may be eligible for often depends on many factors. Therefore, it is important to know as many details as possible with regard to your specific circumstances when searching for clinical trials.  Examples of information you may want to have on hand include the following:

  • Your history of hair loss
  • Your prior and current diagnoses of any other health conditions or diseases.
  • Your current medications (including vitamins, minerals, and other dietary supplements)

Suggested Search Terms:

 “hair loss female,” “hair loss male,” “hair loss child,” “hair loss treatment,” “hair loss stress,” “hair loss cancer,” “hair restoration,” “hair transplant,” “female pattern hair loss,” and “male pattern hair loss.” 

Current Search Term:

“Baldness/Hair Restoration”

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Intervention:   Biological: Platelet-rich Plasma
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Condition:   Frontal Fibrosing Alopecia
Intervention:   Device: Eclipse Easy Spin for PRP
Sponsor:   University of Minnesota - Clinical and Translational Science Institute
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Intervention:   Device: Fractional erbium-glass 1550 nm laser
Sponsor:   Northwestern University
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Condition:   Hair Thinning
Interventions:   Dietary Supplement: Nutrafol Supplement capsules;   Other: Placebo capsules
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Condition:   Hair Loss
Sponsor:   Assiut University
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Interventions:   Drug: CG 428 cutaneous solution;   Drug: Placebo cutaneous solution
Sponsor:   Legacy Healthcare SA

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