Treatment Trials

249 Clinical Trials for Various Conditions

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COMPLETED
ATI-501 Oral Suspension Compared to Placebo in Subjects With Alopecia Areata, Alopecia Universalis or Alopecia Totalis
Description

This Phase 2, multicenter, randomized study will evaluate the safety, tolerability and efficacy of ATI-501 for the treatment of Alopecia Areata (AA), Alopecia Universalis (AU) or Alopecia Totalis (AT) in adult subjects.

Conditions
COMPLETED
Plaquenil for Alopecia Areata, Alopecia Totalis
Description

Alopecia areata is an autoimmune condition resulting in hair loss and complete baldness (alopecia totalis). Published evidence says that it is mediated by T-lymphocytes. Plaquenil is an anti-inflammatory drug approved by the FDA for malaria, lupus erythematosus, and rheumatoid arthritis. It has an effect on T-lymphocyte mediated inflammation, making it a logical choice for a treatment trail for alopecia areata.

Conditions
RECRUITING
Autologous Adipose Cells Therapy
Description

Autologous Adipose Cell Therapy is a series of process designated to address the demerits of the traditional autologous fat grafting and dermal fillers, while enhancing the versatility and aesthetic outcomes. In this study, the goal is to evaluate the safety and efficacy of Autologous Adipose cell Therapy for skin rejuvenation and hair improvement in human application.

COMPLETED
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Female Subjects With Hair Loss
Description

To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in female subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.

COMPLETED
A Study Evaluating the Hair Regrowth Efficacy and Safety of ALRV5XR in Male Subjects With Hair Loss
Description

To demonstrate that the ALRV5XR multi-molecular targeting treatment regimen of a daily shampoo, conditioner, topical serum and oral supplement is superior to placebo in promoting hair growth as assessed by change in hair density and percentage of terminal hair regrowth after ALRV5XR therapy. This will be a single-centre, double-blind, randomized, placebo-controlled study in male subjects randomized to a 1:1 ratio of test article to placebo. Subjects will be asked to use the study products on a daily basis for the duration of the 24-week study. Subjects will take one capsule twice daily (one in the morning and one in the evening) and will be asked to use 3-7mL of the shampoo, 3-7mL of the conditioner, and 1mL of the topical nutriment daily. Subjects will receive detailed instructions regarding the order and duration of application of each product. Subjects in the active arm will receive active capsules, shampoo, conditioner and topical nutriment. Subjects on placebo will receive placebo capsules, shampoo, conditioner and topical nutriment. All subjects will be instructed to take the capsules orally, one in the morning and one in the evening, prior to consuming food. Shampoo and conditioner are to be used once per day when washing the hair and nutriment applied at the end of the day prior to bedtime. To facilitate this, subjects will receive a 3-month supply of each product (supplement, shampoo, conditioner, and scalp nutriment). Subjects will continue the daily regimen for 24 weeks, visiting the clinic at week 12 for an interim assessment.

WITHDRAWN
HairDx Analytical Validation Study
Description

The HairDx Test reports genetic variants associated with the development of FPHL.

COMPLETED
A Study to Evaluate and Compare Injections of Autologous Dermal and Epidermal Cells Into the Balding Scalp of Subjects With Hair Loss (CA-0004512)
Description

The purpose of the study is to evaluate the ability of injections of Ji Gami(TM) or Ji Gami(TM) DO in combination with minoxidil to induce hair growth in male and female subjects with hair loss.

COMPLETED
A Study to Evaluate the Effectiveness and Safety of 5 Percent Minoxidil Foam in the Treatment of Male Pattern Hair Loss
Description

The primary purpose of the study is to evaluate the efficacy of a topical 5% minoxidil formulation in males for the treatment of pattern hair loss. The secondary purpose is to evaluate the safety of a topical 5% minoxidil formulation in males when used twice daily for the treatment of pattern hair loss and to obtain the safety data on the investigational product when used twice daily for up to one year.

ACTIVE_NOT_RECRUITING
A 6-month, Randomized, Double-blind, Placebo Controlled Study Evaluating the Efficacy and Safety of USPlus DERM to Promote Hair Growth in Men and Women With Self-perceived Thinning Hair.
Description

The goal of this clinical trial is to substantiate the effectiveness and safety of USPlus® DERM for self-perceived thinning hair compared to placebo in healthy men and women ages 25-65 over the course of six months of continued use. Participants will be asked to have attend three office visits, one phone call, have photos taken of their hair and answer questionnaires related to their thinning hair.

Conditions
NOT_YET_RECRUITING
Effect of Platelet-Rich Plasma Versus Placebo in the Treatment of Central Centrifugal Cicatricial Alopecia
Description

This study aims to investigate whether platelet-rich plasma (PRP) injections can help treat central centrifugal cicatricial alopecia (CCCA), a type of scarring hair loss that mostly affects women of African descent. CCCA is a condition that leads to permanent hair loss, usually starting at the top of the scalp and spreading outward. It can also cause discomfort, such as itching, burning, and pain. The goal is to see if PRP, which comes from the patient's own blood and is thought to reduce inflammation and promote healing, can stop hair loss and even encourage hair regrowth. PRP has been used to treat other types of hair loss, but it has not been widely studied for CCCA. Participants in the study will be women of African descent who have been diagnosed with mild to moderate CCCA. Some participants will receive PRP injections, while others will receive a placebo (an inactive treatment) as part of a randomized, double-blind trial. All participants will continue using a topical steroid treatment, which is the standard of care for this condition. The study will also look at growth factors in participants' blood to understand how they may affect hair loss or regrowth. The goal is to gather information that could lead to better treatments for CCCA, a condition that currently has no standard treatment guidelines. Although there are risks such as minor discomfort from blood draws and scalp injections and/or a small risk of disease progression, the potential benefits include improved hair growth and a better understanding of CCCA treatments.

NOT_YET_RECRUITING
1550nm Non-ablative Fractional Vs 1927nm Thulium Fractional Laser for the Treatment of Female Pattern Hair Loss
Description

To evaluate the efficacy of either a 1550nm non-ablative fractional laser or a 1927nm thulium fractional laser in the treatment of female pattern hair loss (FPHL).

RECRUITING
A Study of 2 Doses of Ritlecitinib in People 12 Years of Age and Older With Alopecia Areata
Description

The purpose of the study is to learn about the safety and effects of the study medicine (called ritlecitinib) for the treatment of alopecia areata. Alopecia areata is a disease that causes hair loss on the scalp, face, and areas of the body. Ritlecitinib is approved in many countries at a dose of 50 mg (milligram) taken by mouth once a day for the treatment of patients 12 years and older with severe alopecia areata. This study will look at both the 50 mg dose and a 100 mg dose. This study is seeking participants who: * Are 12 years of age or older * Have a diagnosis of alopecia areata * Have lost 50% or more of the hair on their scalp * Do not have any other conditions that causes hair loss * Are willing to stop all other treatments that they may be taking for alopecia areata About 550 participants will take part in in this study. Participants will be chosen by chance, like drawing names out of a hat, to receive 1 of 2 different amounts of ritlecitinib (50 mg and 100 mg) taken by mouth once daily. The 2 doses of ritlecitinib in this study will be compared to each other and also to data from previous studies. This will help to see if the 100 mg dose of ritlecitinib is safe and effective. People will be in this study for about 13 months. During the study, participants will need to visit the study site up to 9 times. Participants will undergo various tests and procedures such as: * alopecia areata assessment, * physical examinations, * hearing tests, * blood tests, * x-ray, * ECG (electrocardiogram), * photographs of the scalp and eyes. Participants will also be asked to complete questionnaires about their alopecia areata.

Conditions
RECRUITING
Portable Scalp Cooling System (PSCS) to Prevent Hair Loss for Breast Cancer Patients (Cooler Heads)
Description

The purpose of this post-market, prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer.

COMPLETED
Penetration-enhanced Direct DBD Non-thermal Plasma for Hair Loss
Description

In-office applied non-thermal atmospheric pressure plasma treatment on NS pretreated scalp

COMPLETED
A Study to Evaluate the Safety, Pharmacokinetics and Efficacy of IMG-007 in Adult Alopecia Areata Participants
Description

The primary objective of the study is to evaluate the safety of IMG-007 in adults with Alopecia Areata.

RECRUITING
A Phase 2a Proof-of-Concept Trial of Bempikibart (ADX-914) for the Treatment of Severe Alopecia Areata (SIGNAL-AA)
Description

Part A is a randomized, double-blind, placebo-controlled, multi-center Proof-of-Concept (POC) Trial in subjects with severe Alopecia Areata. All participants in Part A have completed participation. Part B is a multicenter, open-label study to assess the efficacy, safety, and tolerability of bempikibart (ADX-914) in participants with severe Alopecia Areata.

Conditions
RECRUITING
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss (SCALP2)
Description

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below. * They will be asked about their previous medical history and current medications. * A brief physical examination will be performed. * Vital signs, weight and height will be measured. * Electrocardiograms will be performed. * Subject's scalp will be checked for any signs of irritation. * Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness). * Blood draws and urine sample collection for safety laboratory tests. * Subject will be asked to complete, on site, the following two questionnaires: * Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use. * Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

RECRUITING
A Study to Evaluate the Efficacy and Safety of Clascoterone Solution in Treatment of Male Pattern Hair Loss
Description

The purpose of the study is to see if Clascoterone can help people with male pattern hair loss to recovery and see if the treatment is effective and safe and how well the drug is tolerated by subjects. Within this study, the Clascoterone solution will be compared to a placebo. The study has 2 parts: Part 1 will see if Clascoterone solution is effective and safe compared to a placebo when applied twice daily for up to 6 months. Part 2 will see the long-term safety and efficacy of the Clascoterone solution compared to placebo for additional 6 months in subjects defined as ''responders'' in Part 1. A responder is defined as someone who have responded to the study drug, based on research data. Part 1 of the study is double-blind, meaning that neither the subject nor the study doctor knows which treatment subject is receiving. Part 2 of the study is single-blind and only the study doctor doing the study knows which treatment subject is receiving. Part 1 of the study will start with baseline visit during which subjects will be randomly assigned (by chance) in ratio 2:1 to apply either Clascoterone or placebo solution to their balding areas of the scalp. Subjects will have 5 clinic visits and 2 follow-up phone calls during 6 months of Part 1 duration. Subjects identified as Part 1 responders at Month 6 visit will be again randomly assigned in ratio 2:1 to receive either study drug or placebo. Part 2 of the study will consist of 2 additional clinic visits and treatment will last for further 6 months. Each subject will have also an end of study visit one month after the study drug treatment has been completed or discontinued (it will be one month after end of Part 1 for not responder subjects). For those subjects who complete the whole study (Part 1 and Part 2), the total duration of the study will be about 14 months, with 12 months of treatment with a total of eight clinic visits and two phone calls. Subjects taking part in this study will have the medical tests or procedures described below. * They will be asked about their previous medical history and current medications. * A brief physical examination will be performed. * Vital signs, weight and height will be measured. * Electrocardiograms will be performed. * Subject's scalp will be checked for any signs of irritation. * Two different types of photos will be taken during this study: "global photos", i.e. general photos of the subject's scalp and "macro photos", i.e. close up photos of a region of the subject's scalp. Global photos will be taken to help the subject and the study doctor to assess whether there has been a change in subject's hair growth. Macro photos will be used to count the number of hairs in a region of the subject's scalp and measure other properties of the hair (hair width and hair darkness). * Blood draws and urine sample collection for safety laboratory tests. * Subject will be asked to complete, on site, the following two questionnaires: * Cosmetic Evaluation - a couple of cosmetic questions on acceptability and how easy the study drug is to use. * Male Androgenetic Alopecia Questionnaire - some questions about subject's hair assessment. Eligible subjects will be given a supply of the study drug and shown how to use and store it. The first study drug dose will be applied at the clinic under the supervision of the study staff. Subjects will be instructed to apply about 1.5 ml of study drug with a dropper to the balding areas of the scalp on the vertex and the temples twice daily, once in the morning and once in the evening. Subjects will be asked to bring back all used containers of study drug and all unused study drug to each study visit. Subjects will also be given a diary, shown what things have to be recorded on it and asked to bring back the completed diary to the study center at each visit.

RECRUITING
A Study of Oral Minoxidil to Treat Hair Loss in Children, Teens, and Young Adults Who Are Cancer Survivors
Description

This study will test whether minoxidil taken by mouth (oral minoxidil) can improve hair loss caused by cancer treatment in children and young adults. In addition, the researchers will test the safety of oral minoxidil, and see if the study drug causes few or mild side effects in participants. Other purposes of this study include looking at whether participants are able to follow their study drug dosing schedules, and how oral minoxidil affects participants' quality of life.

COMPLETED
A Study of Revian Red All LED Cap as a Novel Treatment for Central Centrifugal Cicatricial Alopecia
Description

The purpose of this study is to determine if the Revian Red All LED cap shows potential to be an effective treatment for Central centrifugal cicatricial alopecia (CCCA) by recruiting hair follicles back to anagen growth or by improving inflammation. The primary outcome is to determine if hair loss regression is halted. Secondary outcomes include hair regrowth and alleviation of signs and symptoms of the disease. Participants will be asked to use the Revian Red All LED cap once daily for a 10-minute treatment regimen which is the current androgenetic alopecia recommendation.

COMPLETED
Natural History and Pathogenesis of Alopecia in Children and Adults
Description

Background: Alopecia is the loss of hair or lack of hair growth. It is often related to an immune disorder that disrupts the growth of hair. Hair loss can affect a person s physical and mental health. The causes of alopecia are not well understood. This natural history study will examine causes of alopecia so better treatments can be developed. Objective: To learn why some people have alopecia. This study will look at factors related to genes, the immune system, and the bacteria, viruses, and fungi that live on the skin. Eligibility: People aged 2 years and older with immune-mediated alopecia that affects 50% of their scalp hair. Design: Participants will have at least 1 visit to the clinic. Some will have follow-up visits once a year for up to 5 years. Each visit will last 2 to 4 hours. Participants will have a physical exam. They will have blood drawn from a vein. They will answer questions about the medications they take, their allergies, and their family history. Photographs of their skin and scalp will be taken. Soft cotton swabs will be rubbed on their skin to pick up organisms that live there. Two pieces of skin from the scalp will be cut away. The pieces will be no more than a quarter of an inch in size. The area will first be numbed with an injectable anesthetic. The wound will be closed with stitches or gel foam. The biopsy is optional in children younger than 12. Participants will take a questionnaire about how hair loss affects their quality of life.

Conditions
RECRUITING
Study to Assess the Ability of the Portable Scalp Cooling System (PSCS) to Prevent Hair Loss
Description

The purpose of this prospective study is to assess the ability of AMMA to prevent hair loss in women receiving chemotherapy (CT) for early-stage breast cancer. Additionally, the purpose is also to assess the safety, tolerability and compliance, quality of life, and satisfaction with hair preservation after CT treatment.

ACTIVE_NOT_RECRUITING
Use of Botulinum Toxin in the Treatment of Androgenic Alopecia
Description

The purpose of this study is to evaluate the effect of using a purified botulinum toxin (Xeomin®, Merz, USA), the same injectable used to improve face wrinkles, to treat a specific type of hair loss seen in men and women not associated with scarring or other internal disease called 'pattern hair loss'. This type of hair loss is medically called 'androgenic or androgenetic alopecia'. In men it is typically called 'male pattern baldness' whereas in women it is called 'female pattern baldness' and in both cases is hereditary meaning there will be a history of relatives that describe having the same condition.

WITHDRAWN
Hydraderm for Androgenic Alopecia
Description

The study will be focused on evaluating the use of hydradermabrasion on the scalp. The study aims to assess the effect of this treatment on scalp health and hair growth.

RECRUITING
Azelaic Acid as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Description

The purpose of this pilot study is to determine if azelaic acid shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). In this study, the aim is to compare azelaic acid vs placebo since azelaic acid may increase anti-inflammatory effects that affect the hair growth cycle.

WITHDRAWN
Calcipotriol as a Novel Treatment for Central Centrifugal Cicatricial Alopecia (CCCA)
Description

The purpose of this pilot study is to determine if calcipotriol shows potential to be an effective treatment for Central Centrifugal Cicatricial Alopecia (CCCA). This study aims to evaluate calcipotriol due to the possible anti-inflammatory effects that may affect the hair growth cycle.

RECRUITING
Evaluate the Efficacy and Safety of Ruxolitinib on Hair Regrowth in Patients With Autoimmune Polyendocrinopathy Candidiasis Ectodermal Dystrophy (APECED)-Associated Alopecia Areata
Description

Background: Autoimmune polyendocrinopathy candidiasis ectodermal dystrophy (APECED) is a problem of the immune system. In people with APECED, the immune system makes a mistake and attacks the body. Some people with APECED have a type of hair loss called alopecia areata (AA). No drugs are approved to treat AA. Objective: To see if a study drug (ruxolitinib) can help hair regrowth in people with APECED-associated AA and if it can improve other symptoms caused by the immune system s attack to the body. Eligibility: People aged 12 to 65 years with APECED and severe AA. Design: Participants will be in this study for up to 10 months. They will have 5 in-person visits and 6 televisits, each about 4 weeks apart. One in-person visit may be up to a 10-day stay in the hospital. The first in-person visit will include screening. Participants will have a physical exam. They will have blood tests. Photographs may be taken of their skin. They will answer questions about their quality of life. Participants will begin taking the study drug during their hospital stay. They will take the pills by mouth twice a day for 8 months. Researchers may take tissue samples from participants scalp, gums, and lower lip. Participants may provide samples of urine, stool, nail clippings, and saliva. They may have an eye exam and an ultrasound exam of their abdomen. Some tests may be repeated in subsequent in-person visits. In telehealth visits, participants will answer questions about how they are feeling. They will describe and send photos of hair regrowth. They will be asked to have blood drawn and the results sent to the researchers.

COMPLETED
Activated PRP for Treatment of Androgenetic Alopecia
Description

A clinical trial to assess the effects and safety of PRP activated with pulsed electrical fields (PEFA-PRP) compared with unactivated PRP when used to treat AGA. The design of this small-scale, phase 1b/2a clinical trial is to demonstrate that pulsed electric field activation of autologous PRP results in a controlled release of platelet growth factors and other biologically active molecules that will have a benefit effect on the non-cycling hair follicles in the treated scalp compared to non-activated PRP. This single-center, auto-controlled study will compare the clinical benefit of PEFA-PRP versus non-activated PRP treatment of male patients with AGA.

COMPLETED
To Evaluate Efficacy, Safety, and Tolerability of KX-826 in Male Subjects With Androgenetic Alopecia
Description

The study is a randomized, double-blind, placebo-controlled, parallel group, phase 2 study to evaluate the efficacy, safety and tolerability of KX-826 in male subjects with androgenetic alopecia.

COMPLETED
Dual JAK1/TYK2 Inhibitor for Cicatricial Alopecia
Description

Alopecia could be subdivided into two main groups of diseases: non-scarring alopecia, such as male pattern baldness, or alopecia areata (AA), in which hair follicles are preserved, yet quiescent, and scarring alopecia, also known as cicatricial alopecia (CA), in which hair follicles are irreversibly destroyed. CA leads to scarred areas, most commonly on the scalp, that cannot re-grow hair. Despite being a long-term condition, that often has significant impact on patients' well-being, available effective treatments for these diseases are lacking. In addition, the molecular abnormalities causing CA are largely unknown. The study team's research involves administrating patients a new investigational drug (a combined TYK/JAK inhibitor) which has been shown to be safe and well tolerated in clinical studies to date, and is being investigated in other conditions, such as AA. CA patients will be asked to provide small samples of skin and blood throughout the treatment period, to find out how they respond to the drug, and to attempt to better understand these diseases.