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Valchlor

Phase 1

Skin Irritation | Small molecule | Dermatology |Community Health Systems, Inc.|Last Updated: Dec 23, 2021

Success Probability

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Market & Valuation

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Trial Design

RandomizedDouble-BlindPLACEBO_CONTROLLED
Total Trials1
Total Enrollment33

FDA Designations

No designations recorded

Clinical trial landscape

Valchlor · 1 trial · 1 indication

Early Phase 1 1
NCT02968446Effect of Vitamin D After Application With ValchlorSkin Irritation
COMPLETED33 Analytics
EARLY_PHASE1COMPLETED
Effect of Vitamin D After Application With Valchlor
Skin IrritationUnlock trial analytics

Study Endpoints

Primary Endpoints

Change in skin erythema
Up to 1 week after mechloroethamine exposure

Skin erythema (redness) will be quantified using a CR300 chromameter. The difference in erythema between exposed and non-exposed skin will be calculated after valchlor exposure

Secondary Endpoints

Change in skin thickness
Up to 1 week after mechloroethamine exposure
Change in TNF-alpha expression
Up to 120 hours after mechloroethamine exposure
Change in iNOS expression
Up to 120 hours after mechloroethamine exposure
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Study Design & Arms

AllocationRANDOMIZED
MaskingDOUBLE
ModelPARALLEL
PurposeSUPPORTIVE_CARE

Treatment Arms

ArmTypeDescription
Group 1: 4 placebo - 0 Vitamin D with ValchlorPLACEBO_COMPARATORParticipants will be given 4 placebo capsules and 0 cholecalciferol (Vitamin D) capsules after being treated with Valchlor.
Group 2: 0 placebo - 4 Vitamin D with mechloroethamineEXPERIMENTALParticipants will be given 0 placebo capsules and 4 cholecalciferol capsules to total 200,000 IU of cholecalciferol (Vitamin D) after being treated with Valchlor.

Interventions

NameTypeDescription
4 placeboDIETARY_SUPPLEMENTsubjects will take orally 4 pills without any active ingredients which are of the same size, shape and color as the study pills
4 Vitamin DDIETARY_SUPPLEMENTsubjects will take orally four pills for a single dose of 200,000 IU of Vitamin D (cholecalciferol)
ValchlorDRUGTwice during the study, subjects will be given 0.016% Valchlor at 3 locations (for a total of 6 locations) in the inner arm using Finn ChambersTM
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Eligibility Criteria

Age Range18 Years to N/A
SexALL
Healthy VolunteersNo
Study Sites1

Inclusion Criteria: * Must be in general good health * Fitzpatrick Skin Type I-VI * Able to list all current medications and medical conditions * Capable of giving informed consent Exclusion Criteria: * Women who are pregnant, nursing, or who may become pregnant in the next 3 months * Participant...

Countries:United States
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