Atopic Dermatitis Clinical Trial
Official title:
A Pilot Ex-vivo Study to Evaluate the Effect of Pimecrolimus on Antimicrobial Peptide Expression and Vaccinia Virus Growth in Perilesional Skin Cultures of Patients With Atopic Dermatitis
THe study seeks to determine if pimecrolimus has a positive effect on increasing antimicrobial peptide expression and reducing vaccinia virus growth in the skin explants from patients with atopic dermatitis.
AMP play an important role in the innate immune response against infections. Two major
classes of AMP have been identified: the beta defensins (HBD) (Harder 1997) and
cathelicidins (LL-37) (Gallo 2002). AMP have been shown to have antibacterial activities
against S. aureus (Ong 2002) and antiviral activity against vaccinia virus (VV) (Howell
2004).
The skin of AD patients is characterized by a deficiency in AMP, which may account for their
propensity to skin infections (Ong 2002). This AMP deficiency is believed to be due to an
increase in Th2 cytokines, IL-4 and IL-13, expression (Ong 2002), as well as an increase of
IL-10 expression (Howell 2005). Other cytokines known to affect AMP expression are TNF-alpha
(TNFa), IL-6, IL-1 and interferon-gamma (IFN-g). These cytokines induce the expression of
AMP (Erdag 2002, Liu 2002, Ong 2002, Nomura 2003). However, negligible levels of TNF-a and
IFN-g have been shown in AD skin possibly due to their downregulation by Th2 cytokines
(Nomura 2003). Therefore, the neutralization of IL-4, IL-13 and IL-10 in AD patients may
correct the AMP deficiency of AD patients and decrease their propensity to recurrent skin
infections. Interestingly, the addition of anti-IL10 to skin explants from AD patients
augmented HBD-2 and LL-37 expression (Howell 2005). In addition, IL-4 and IL-13 were found
to enhance VV replication and down-regulate LL-37 in VV-stimulated keratinocytes and
neutralization of IL-4/IL-13 in AD skin augmented LL-37 and inhibited VV replication (Howell
2006a). LL-37 and HBD-3 have been found to kill VV(Howell 2004; Howell 2006b). Thus a
deficiency of these AMP may contribute to increased propensity to viral infection.
Therapeutic strategies are needed to augment AMP expression in AD skin to reduce skin
infection.
Pimecrolimus is a calcineurin inhibitor that binds with high affinity to macrophilin-12. The
complex pimecrolimus-macrophilin inhibits calcineurin, a phosphatase required for the
dephosphorylation of the cytosolic form of the nuclear factor of activated T cells (NF-AT).
As a consequence, pimecrolimus prevents the nuclear translocation of NFAT and thereby the
transcription and release of both Th1 and Th2 cytokines such as IL-2, IFN-g, IL-4, IL-5,
IL-10, TNF-a and GM-CSF (Grassberger 1999).
As the most common topical corticosteroid treatment used by AD patients, triamcinolone
diacetate is included in this study as an active comparator.
;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05018806 -
Proof of Concept Study of Rilzabrutinib in Adult Patients With Moderate-to-severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04090229 -
A Multi-center, Randomized, Double-blind, Placebo-controlled, Multiple Ascending Dose Study of the Safety, Tolerability, and Pharmacokinetics of Subcutaneously Delivered ASLAN004 in Adults With Moderate-Severe Atopic Dermatitis
|
Phase 1 | |
| Terminated |
NCT03847389 -
Clobetasol Topical Oil for Children With Moderate to Severe Atopic Dermatitis
|
Phase 1/Phase 2 | |
| Active, not recruiting |
NCT05388760 -
Tralokinumab Monotherapy for Children With Moderate-to-severe Atopic Dermatitis - TRAPEDS 1 (TRAlokinumab PEDiatric Trial no. 1)
|
Phase 2 | |
| Completed |
NCT05530707 -
Evaluation of Acceptability, Skin Barrier Restoration and Balance of Atopic Skin Using Moisturizer
|
N/A | |
| Completed |
NCT02595073 -
Clinical Study to Evaluate the Efficacy and Safety of Desoximetasone (DSXS) With Atopic Dermatitis
|
Phase 3 | |
| Recruiting |
NCT05509023 -
Evaluating Safety and Efficacy of ADX-914 in Patients With Moderate to Severe Atopic Dermatitis (SIGNAL-AD)
|
Phase 2 | |
| Recruiting |
NCT05048056 -
Phase 2 Study of Efficacy and Safety of AK120, in Subjects With Moderate-to-Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04598269 -
Study of ATI-1777 in Adult Patients With Moderate or Severe Atopic Dermatitis
|
Phase 2 | |
| Recruiting |
NCT03936335 -
An Observational Retrospective Cohort Study Being Conducted in Women With Atopic Dermatitis (AD)
|
||
| Withdrawn |
NCT03089476 -
Evaluating Skin Barrier Dysfunction in Infants at High Risk of Atopy
|
N/A | |
| Recruiting |
NCT05029895 -
A Study to Evaluate Adverse Events and Change in Disease State of Oral Upadacitinib in Adolescent Participants Ages 12 to <18 Years Old Diagnosed With Atopic Dermatitis (AD)
|
||
| Terminated |
NCT03654755 -
Study to Evaluate Long-Term Safety of ASN002 in Subjects With Moderate to Severe Atopic Dermatitis
|
Phase 2 | |
| Completed |
NCT04556461 -
Effects of Tralokinumab Treatment of Atopic Dermatitis on Skin Barrier Function
|
Phase 2 | |
| Recruiting |
NCT04818138 -
BROadband vs Narrowband photoTherapy for Eczema Trial Nested in the CACTI Cohort
|
N/A | |
| Completed |
NCT03719742 -
A Clinical Study to Evaluate the Safety and Efficacy of a Baby Cleanser and a Moisturizer
|
N/A | |
| Completed |
NCT05375955 -
A Study to Learn About The Study Medicine (PF-07038124) In Patients With Mild To Moderate Atopic Dermatitis Or Mild To Severe Plaque Psoriasis.
|
Phase 2 | |
| Completed |
NCT03441568 -
In-home Use Test of the New Modified Diprobase Formulation to Assess the Safety and Tolerability in Infants and Children Under Physician's Control
|
N/A | |
| Recruiting |
NCT06366932 -
Optimization of Atopic Dermatitis Treatment That Requires Second-line Systemic Therapy Through Predictive Models
|
Phase 4 | |
| Completed |
NCT03304470 -
A Study to Evaluate the Safety and Efficacy of ATx201 in Subjects With Moderate Atopic Dermatitis
|
Phase 2 |