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Hydrocortison

Phase 2

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

Success Probability

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Market & Valuation

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Trial Design

RandomizedCONTROLLED
Total Trials1
Total Enrollment40

FDA Designations

No designations recorded

Clinical trial landscape

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 in Atopic Dermatitis?

Hydrocortison is a small molecule being developed for the treatment of atopic dermatitis, a chronic inflammatory skin condition. It is currently in Phase 2 clinical development and is being studied as an investigational therapy for this indication.

Who makes Hydrocortison?

Hydrocortison is being developed by Bayer AG, a multinational pharmaceutical company. Bayer AG is publicly traded under the ticker symbol BAYRY.

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 by regulatory authorities. One Phase 2 trial has been completed.

What clinical trials is Hydrocortison in?

Hydrocortison has one completed Phase 2 clinical trial, identified as NCT00980135, titled 'Sinecort Pilot Efficacy Study'. This trial enrolled 40 participants with atopic dermatitis in Germany and was a controlled, randomized study.

Is Hydrocortison the same as Sinecort?

Hydrocortison is associated with the trial title 'Sinecort Pilot Efficacy Study', which suggests that Sinecort may be an alternative name for the drug. The trial NCT00980135 is the only clinical trial listed for this drug.