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Hydrocortison

Phase 2

Atopic Dermatitis | Small molecule | Dermatology |Bayer AG|Trials Updated: Apr 2, 2014

Hydrocortison target and mechanism

Molecular targetNR3C1
Target classAgonist
ModalitySmall molecule

Also known as Hydrocortison cream

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Hydrocortison clinical trials

Hydrocortison · 1 trial · 1 indication

Phase 2 1
NCT00980135Sinecort Pilot Efficacy StudyAtopic Dermatitis
COMPLETED40 Analytics
PHASE2COMPLETED
Sinecort Pilot Efficacy Study
Atopic DermatitisUnlock trial analytics

Study Endpoints

Primary Endpoints

Efficacy rate versus comparator and untreated skin
After 29 days of twice daily applications
Local side effects on the skin
29 days

Secondary Endpoints

Local SCORAD as clinical assessment by means of the intensity items of the SCORAD index) at Visit 2 through Visit 6
after 29 days
Transepidermal water loss (TEWL) as a measure for skin barrier function at Visit 2 through Visit 6
after 29 days
Skin hydration by means of corneometry at visit 2 through visit 6
after 29 days
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Study Design & Arms

AllocationRANDOMIZED
MaskingSINGLE
ModelPARALLEL
PurposeTREATMENT

Treatment Arms

ArmTypeDescription
Arm 1EXPERIMENTAL -
Arm 2EXPERIMENTAL -
Arm 3OTHER -

Interventions

NameTypeDescription
Sinecort creamDEVICEApplication over 29 days
Hydrocortison creamDRUGApplication over 29 days
Untreated skinOTHER -
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Eligibility Criteria

Age Range18 Years to 65 Years
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Male or female Caucasians aged between 18 and 65 years * Patients with mild AD presenting a scoring AD (SCORAD) rating between 3-25 * Skin type I - IV according to Fitzpatrick * Acute AD symptoms on each assessment areas (local SCORAD \>/=3 and \<= 12) * Acute symptom of pruri...

Countries:Germany
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Frequently asked questions about Hydrocortison

What is Hydrocortison used for?

Hydrocortison is a small molecule being developed for atopic dermatitis, a form of eczema. It is a topical therapy studied in adults with the condition. Development is at Phase 2, so it is investigational and not yet an approved treatment for atopic dermatitis.

What does Hydrocortison target?

Hydrocortison targets NR3C1, the glucocorticoid receptor, and acts as an agonist at that receptor. Agonist activity at NR3C1 is the mechanism by which the drug is intended to act in atopic dermatitis. The compound is a small molecule administered as a topical cream.

Who makes Hydrocortison?

Hydrocortison is being developed by Bayer AG, which trades under the ticker BAYRY. Bayer is the sponsor behind the clinical development program for the drug in atopic dermatitis.

What phase is Hydrocortison in?

Hydrocortison is in Phase 2 clinical development for atopic dermatitis. It is an investigational drug and has not been approved for marketing. One Phase 2 trial has been completed, and no trials are currently listed as active.

What clinical trials is Hydrocortison in?

Hydrocortison has been studied in the Sinecort Pilot Efficacy Study, registered as NCT00980135. That Phase 2 trial was completed in Germany and enrolled 40 adults with atopic dermatitis. It was randomized and controlled, and it was not double blinded.

Is Hydrocortison the same as Hydrocortison cream?

Yes, Hydrocortison cream is another name for Hydrocortison. Both names refer to the same topical small molecule developed by Bayer AG for atopic dermatitis, so searches using either name point to the same investigational asset.