Apremilast in the Treatment of Moderate to Severe Acne
Summary
Acne is a chronic inflammatory disease of the pilosebaceous unit that affects 80-90% of the population, especially teenagers, although adult acne is a significant problem for 3-6 % of adult men and 5-12% of adult women. Although acne is not a life-threatening disease, it produces significant psychological disturbances and permanent skin scars.
A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are elevated in inflammatory acne.
Our intention is to study Apremilast in the treatment of moderate to severe acne.
Description
The hypothesized sequence of events in inflammatory acne starts with the formation of a microcomedone with accumulation of cornified keratinocytes within the follicle. Presence and/or proliferation of P.acnes induces the production of IL-1 alpha, tumor necrosis factor (TNF)- alpha, IL-8 and granulocyte-macrophage colony-stimulating factor (GM-CSF). Inflammation caused by CD4+ T cells causes a T-helper 1 cytokine response mediated by Toll-like receptors (TLR)-2 and TLR-4 whose expression is increased by P. acnes. Infiltration by neutrophils appears 72 hrs after, with possible disruption of the follicular wall and more inflammation. TNF-alpha liberated by keratinocytes stimulates the activation of pro-matrix metalloproteinase (MMP)-2 activity in the dermis with remodeling by fibroblasts with the consequence of possible scarring.
The usual treatment for moderate to severe inflammatory acne involves the use of long-term topical retinoids and antibiotics such as doxycycline or minocycline that had been showed to decrease the inflammatory response as well as decreasing the population of P. acnes. Since acne is a long term condition, several years of antibiotics are usually required. Recently, the problematic of antibiotic overuse has received great attention and concerns. Chronic antibiotic use has been implicated in increasing the risk of breast cancer and upper respiratory infections, and there is also a concern for antibiotic resistance. Recent recommendations by the Global Alliance to Improve Outcomes in Acne Group include the limitation for the use of oral antibiotics to a maximum of 3 months. So there is a need to find alternatives that does not include the use of oral antibiotics.
The only effective and available treatment for severe acne is isotretinoin which may have potential serious side effects. Lately also it has been implicated in the development of depression and suicidal ideations in the teenager population.
A novel anti-inflammatory, not antibiotic drug may be an excellent alternative for the treatment of moderate to severe acne. Apremilast has been shown to inhibit the production of tumor necrosis factor (TNF)-alpha, IL-8 and neutrophil infiltration, all of which are elevated in inflammatory acne. Preliminary data of the use of Apremilast in psoriasis makes us believe that this medication is safe for short-term use in acne patients.
Our intention is to study Apremilast in the treatment of moderate to severe acne.
Study Design
Control: Uncontrolled, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Conditions
Acne
Intervention
apremilast
Location
University Of North Carolina
Chapel Hill
North Carolina
United States
27516
Status
Recruiting
Source
University of North Carolina, Chapel Hill
Results (where available)
Links
- Source: http://clinicaltrials.gov/show/NCT01074502
- Information obtained from ClinicalTrials.gov on July 15, 2010
Published on BioPortfolio: 2014-08-27T03:15:42-0400
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Medical and Biotech [MESH] Definitions
Acne Conglobata
Severe and chronic form of acne characterized by large, burrowing abscesses associated with disfigurement.
Acneiform Eruptions
Visible efflorescent lesions of the skin caused by acne or resembling acne. (Dorland, 28th ed, p18, 575)
Adapalene
A naphthalene derivative that has specificity for RETINOIC ACID RECEPTORS. It is used as a DERMATOLOGIC AGENT for the treatment of ACNE.
Isotretinoin
A topical dermatologic agent that is used in the treatment of ACNE VULGARIS and several other skin diseases. The drug has teratogenic and other adverse effects.
Benzoyl Peroxide
A peroxide derivative that has been used topically for BURNS and as a dermatologic agent in the treatment of ACNE and POISON IVY DERMATITIS. It is used also as a bleach in the food industry.
