Apremilast for RAS

Conditions

• Recurrent Aphthous Stomatitis

Eligibility Criteria

Sex

ALL

Age

18 Years - 70 Years

Healthy Volunteers

Not accepted

Interventions

• Apremilast 30mg — DRUG
  Apremilast is an oral small-molecule inhibitor of phosphodiesterase (PDE) 4 that works intracellularly to modulate a network of pro-inflammatory and anti-inflammatory mediators. PDE 4 is a cyclic adenosine monophosphate (cAMP)-specific PDE and the dominant PDE in inflammatory cells. PDE4 inhibition elevates intracellular cAMP levels, which in turn down-regulates the inflammatory response by modulating the expression of TNF-alfa, IL-23, IL-17 and other inflammatory cytokines. Cyclic AMP also modulates levels of anti-inflammatory cytokines such as IL-10. Apremilast has immunomodulatory activity and, therefore, has the potential to be effective in the treatment of RAS.

Study Details

Determination of treatment efficacy and safety of Apremilast in patients with RAS

Key Dates

First listed

Oct 1, 2018

Start date

Oct 12, 2018

Status verified

Jun 2022

Primary completion

Jul 14, 2021

Completion

Jul 14, 2021

Study Design

Enrollment

15 participants (actual)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Single Arm
  Apremilast 30mg orally twice daily for 16 weeks, sixteen weeks on active study. Post treatment follow-up period of 8 weeks, in the Treatment of Subjects with Severe Recurrent Aphthous Stomatitis (RAS)

Primary Outcome Measure

Duration of RAS Lesions [ Time Frame: 24 weeks ]

Locations (1)

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