Acne Vulgaris / Acne - Tampa Clinical Trial
Forward Clinical Trials is leading a new research study for participants 9 years of age and above with moderate to severe acne vulgaris. If you or your child struggles with moderate to severe acne vulgaris, a clinical research study may be an option for you. Reimbursement may be available for time and travel.
Qualified participants are:
- 9 years of age or above
- Diagnosed with moderate to severe acne vulgaris.
- Willing to commit to study visits
- Able to apply a topical medication
Participants are paid for their time and travel considerations.
All study related tests, visits and investigational product are at no cost to the participant.
What Is Acne Vulgaris?
Acne, also known as acne vulgaris, is a long-term skin disease that occurs when hair follicles are clogged with keratin (dead skin cells) and oil from the skin. It is characterized by open comedones (blackheads). closed comedones (whiteheads), pimples, inflammatory nodules, pustules, oily skin, and possible scarring. It primarily affects areas of the skin with a relatively high number of hair follicles and sebaceous glands, including the face, shoulders, upper part of the chest, and back. The resulting appearance can lead to anxiety, reduced self-esteem and, in extreme cases, depression or thoughts of suicide.
Genetics is thought to be the primary cause of acne in 80% of cases. The role of diet and cigarette smoking is unclear, and neither cleanliness nor exposure to sunlight appear to play a part. During puberty, in both sexes, acne is often brought on by an increase in hormones such as testosterone. A possible factor is excessive growth of the bacterium Propionibacterium acnes, which is normally present on the skin.
Who Gets Acne Vulgaris?
Acne is estimated to affect 633 million people globally, making it the 8th most common condition worldwide. Acne most commonly occurs in adolescence and affects an estimated 80–90% of teenagers in the Western world. Lower rates are reported in some rural societies. Children and adults may also be affected before and after puberty, respectively. Although acne becomes less common in adulthood, it persists in nearly half of affected people into their twenties and thirties and a smaller group continue to have difficulties into their forties.
Acne is also associated with other conditions such as Polycystic Ovarian Syndrome (PCOS) and other conditions affecting hormonal balance. Additionally, acne may be a side effect of common medications, such as systemic steroids (glucocorticoids), lithium, isoniazid, hydantoin and testosterone.
Signs and Symptoms of Acne Vulgaris
- Keratin plugged openings to the skin are either open comedones (blackheads) or closed comedones (whiteheads). The comedy or comedones are the most common and basic presentation of acne vulgharis
- Inflammatory Nodules. Closed, small cyst like spaces below the skin are erythematous (red) and often painful. There may or may not be drainage.
- Inflammatory Cysts. Large, inflamed cysts that drain spontaneously or will drain with trauma. These are the most likely cause of long term scarring.
- The scarring of acne is often due to the prior inflammatory nodules and cysts. Comedones do not generally result in scarring unless traumatized.
- Pitted Scars - crateriform, depressed areas of a prior inflammatory lesion
- Hypertrophic Scar - raised, smooth scar within the boundary of a prior inflammatory lesion. These may be pruritic (itchy) or painful.
- Keloid - raised, smooth scar outside the boundary of a prior inflammatory lesion. Keloids often occur on the chest and shoulders and less commonly on the face. Keloids are more likely to be pruritic or painful than hypertrophic scars.
Effects of Acne Vulgaris
Acne Vulgaris affects far more than just the skin. Acne Vulgaris can have a severe and measurable affect on the quality of life. Affected patients with Acne Vulgaris may experience the following:
- Permanent Scars
- Low Self Esteem
Management and Treatment of Acne Vulgaris
The management and treatment of Acne Vulgaris ranges from over the counter topical formulations to oral medications that require monitoring of laboratory values. Some of the more aggressive therapies may require co-management with pediatrician and obstetrician. Strategies include:
- Individual. Maximizing personal hygiene.
- Over the Counter (OTC). Benzoyl Peroxide, Salicylic Acid, Toners, Acid Peels
- Topical - Erythromycin, Clindomycin, Dapsone
- Oral - Tetracyclines, Docycycline, Minocycline, Trimethoprim-Sulfamethoxale, Cephalexin, Amoxicillin, Ciprofloxacin, Levofloxacin
- Topical - Tretinoin, Adapalene, Tazarotene
- Oral - Isotretinoin (Accutane, Myorisan, Amnesteen, Clavaris, Absorica)
- requires monthly laboratory monitoring
- requires monthly pregnancy tests (females only)
- requires monthly office visits
- possible induction of depression/suicidal ideations
- Hormonal Therapy. Estrogen based contraceptives, spironolactone.
- Surgical Therapy. Extractions for comedones, scar revisions for pitted, hypertrophic and keloid scars, subcision for pitted scars, carbon dioxide or erbium laser resurfacing and/or deep or medium depth acid peel.
- Photodynamic Therapy. Aminolevulinic acid with blu light exposure
- Radiation Therapy. No longer utilized
Acne Vulgaris Expectations
Acne Vulgaris is a waxing and waning condition. It can be well controlled under some circumstances, and flare under other circumstances. Natural and expected changes in hormones may trigger a flare of acne. If hormonal imbalances occur, a referral to an obstetrician or an endocrinologist is recommended. Certain moisturizers or cosmetics may be comedogenic (acne or comedones causing).
Most of the therapies discussed are not curative. However, removing. agents that cause a flare of acne (cosmetics, medications) can “cure” that type of acne.
Most cases of acne may require combination therapy in order to address the multiple causes of acne vulgaris. The topical therapies are often used in combination for mild to moderate cases. Moderate to severe cases often utilize multiple topical therapies and may add an oral antibiotic. Severe and scarring cases requires isotretinoin. IIsotretinoin requires close clinical monitoring, but may be curative. Patients can not have any elective procedure for scar revisions until at least one year after the final dose of isotretinoin.
Severe nodulocystic acne along with acne-like lesions in the groin, axillae (armpits), breasts, back and posterior neck is likely to be associated with Hidradenitis Suppurativa (also known as acne inverse) in this instance the therapies for Hidradentitis Suppurativa is slightly different and often times more aggressive than Acne Vulgaris alone.
Ready to find out more?
If you have been told or know/believe that you and/or your child (age 9+) suffer from Acne Vulgaris, please click on the button, which will allow you to learn more about this clinical study.