Skin Conditions

Clinical Trials for Patients With Dermatological Conditions

Acne / Acne Scarring

Acne, or acne vulgaris (common) is an inflammatory process with affects tiny hair follicles on the face, chest, back and shoulders affecting over 90 % of teenagers. It is associated with papules (red bumps), pustules, open comedones (black heads) and closed comedones (tiny white firm papules). Acne usually resolves during the mid-twenties. In some individuals acne may persist into senior years. Factors proposed to be associated with the severity of and persistence of acne include: tobacco, sun, diets high in cholesterol, use of skin and hair products that promote acne (comedogenic products) and abrasive skin care. Treatment response varies among acne patients; new treatments are under development for those who fail to respond to current treatment. Many patients with acne can develop scarring. This may be associated with trauma to the lesions; but equally occurs spontaneously from the acne process on its own. Treatments for acne scarring are under development.

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Alopecia Areata

Alopecia Areata (AA) is considered to be an autoimmune disorder wherein the immune system destroys hair follicles in circular patches (areas).  When < 100% of the scalp is involved the disease is called alopecia areata or patchy alopecia areata. Alopecia Totalis (AT)  is when all of the hair on the scalp is lost; Alopecia Universalis (AU) refers to loss of hair throughout the body including the scalp.  AA affects both males and females as well as children and adults. Tendency to the disease may run in families. AA may result from a combination of genetic predisposition, immunological disfunction, combined with hormonal and metabolic disorders.  Many patients with AA also have thyroid disease, vitamin D deficiency, iron and/or copper deficiency; either alone, combined or combined with other hormonal, autoimmune, and/or nutritional disorders.  In many patients AA is mild and spontaneously resolves.  In others, the disease persists with or without periods of remission. 

Treatments are directed at interfering with the immune reaction; thus, allowing the hair to grow.  There is no current FDA approved treatment for AA.  The mainstay treatments involve injected steroids, as well as topical or systemic medications.  Excimer laser which emits UV radiation has been found in small studies to successfully treat AA but not AU nor AT patients. Some patients have responded well to JAX inhibitors, even those who had long standing disease.  After years of neglect, the pharmaceutical industry now appears to be focused on finding one or more successful treatments.

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Atopic Dermatitis/Eczema

Atopic Dermatitis, often is referred to as eczema. Eczema refers to multiple different inflammatory rashes. Atopic Dermatitis is a chronic relapsing itchy variant of eczema seen in patients who have, or have family members with “atopy”. Atopy often includes other allergy based disorders seen in the patient and/or relatives: asthma, hay fever, and conjunctivitis, sensitivity to foods, wool as well as other skin and systemic findings.

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Common Warts

Warts are a viral infection caused by exposure to the human papilloma virus (HPV). Over 170 subtypes of HPV have been identified. HPV types 1, 2, 4, and 7 are associated with common warts. Wart infections spread from one person to another through skin contact (No frogs nor toads are involved). Common warts often resolve without treatment within months once the body’s immunity recognised and destroys the virus. In many patients this immunity fails to develop and warts and persist for months to years. Treatments include destruction of the skin infected through cryosurgery (liquid nitrogen), podophyllotoxin; lasers; or electrosurgery; imiquimod is a topical agent used to enhance the immune response to the virus. New treatment are under development of those patient who despite these options fail to respond or cannot tolerate these treatments.

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Gorlin Syndrome (Basal Cell Carcinoma Nevus Syndrome, BCCNS)

BCCNS is a genetic disorder affecting the skin as well as multiple internal organs. Patients with this syndrome develop many basal cell carcinomas (BCC’s). Some patients may have dozens of BCCs as children and adolescents. They may have bone abnormalities involving the spine, ribs, extremities as well as jaw bone cysts (KCO’s). The primary genetic defect occurs on chromosome 9 at the PTCH locus. This defect activates the Hedgehog pathway leading to tumor growth. Recently, medications have been developed that inhibit the hedgehog pathway and may help to reduce tumor size and/or prevent new tumors. Nonetheless, these medications have many side effects that may limit their use. New drugs are being developed and tested.

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Hidradenitis Suppurativa

Hidradenitis Suppurativa (HS), also known as Acne Inversa, is a disorder is an inflammatory process that affects the apocrine glands and surrounding tissue. Patients develop frequently painful boils, cysts and scarring tracks in the armpits, groin, buttocks and under breasts. There is no clear understand about what causes the disease. Obesity, alcohol, and tobacco aggravate the severity of the disease. Patient may also suffer from diabetes, metabolic syndrome, heart disease, arthritis, and inflammatory bowel disease. Women may have polycystic ovary disease.

HS is treated with antiibiotics, anti-androgens, steroid injections, immunomodulatory compounds, and biologics. Humira, an anti-TNF is an FDA approved treatment. Unfortunately, there is no treatment which universally controls the disease in all patients. Some patients who fail the medications will have the areas involved surgically removed. Weight loss is associated with significant disease improvement; in some, complete control.

IDEOM (International Dermatology Outcome Measures) is a unique group which unifies the efforts of patients, patient advocacy groups, clinicians, researchers, scientists, pharmaceutical and devices company officials, insurers, and regulatory agencies (FDA, etc) to identify what constitutes successful disease treatment/control from a patient perspective. Anyone interested in helping with this process may qualify to attend the IDEOM meetings.

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Prurigo Nodularis (PN)

Prurigo Nodularis (Greek for itchy bumps) is a disorder characterized by multiple firm red itchy nodules.   PN affects males and females equally for all ages, although primarily ages 20-50.  A majority of the PN patients also have atopic dermatitis, asthma and hay fever. In addition, patients suffer from internal disorders including iron deficiency, anemia, vitamin B12 and/or folic acid, as well as other systemic diseases. No specific individual cause has been identified; perhaps, due to a possible of variety of issues leading to a common endpoint of uncontrolled itching. It is theorized that patients with PN become fixated with scratching individual sites until the skin callouses and nodules of inflamed skin appear. Some individual lesions may resemble a squamous cell carcinoma, a skin cancer. Thus, biopsies may be performed to confirm the overall diagnoses as well as separate individual lesions from isolated cancer.

PN is resistant to most treatments. Individuals may respond to a variety of topical creams, oral and injected medications. Sometimes UV radiation may be helpful. Recently, there has been an increase interest from the pharmaceutical industry of developing a treatment. 

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Psoriasis is a chronic inflammatory skin condition associated with red thick scaling. It can occur in children and adults. When mild, psoriasis can be treated with topical steroids. When more severe various oral and injectable medications are available. Multiple new treatments are in clinical trials. Psoriasis is often associated with psoriatic arthritis, metabolic syndrome, diabetes and cardiovascular disease. The severity of psoriasis is associated with body mass, tobacco exposure and drinking alcohol.

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Vitiligo is felt to be an autoimmune disorder wherein pigment cells are destroyed leaving the skin with white patches. The affected skin appears similar to the coloring of the hides of a calf (latin: vitulo). Vitiligo is not contagious, but can resemble some contagious disorders such as tinea versicolor (common) and pinta (rare). Vitiligo appears to result from a combination of genetic, biochemical, immunological and neurological factors. The disease may run in families. Rarely, it is a sign of mole that is changing toward melanoma. Vitiligo may be associated with other autoimmune disorders such as thyroid disease, diabetes, systemic lupus erythematosus (SLE), alopecia areata, Vitamin B12 deficiency, and Addison disease. The pigment destruction may extend to the retina (eye), the inner ear leading to visual and hearing disorders. More frequently, vitiligo is limited to the skin surface and is not associated with internal disease.

Currently, there is no FDA approved treatments. Various individuals have responded to different topical medications, oral /injected immunomodulatory drugs, diet changes, and UV treatments. When the disease is extensive some patient elect to have the remaining pigment destroyed (such as Michael Jackson).

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IDEOM (International Dermatology Outcome Measures)

IDEOM (International Dermatology Outcome Measures) is a unique group which unifies the efforts of patients, patient advocacy groups, clinicians, researchers, scientists, pharmaceutical and devices company officials, insurers, and regulatory agencies (FDA, etc) to identify what constitutes successful disease treatment/control from a patient perspective. Anyone interested in helping with this process may qualify to attend the IDEOM meetings.