Testing an Intervention in Irritative Contact Dermatitis
Testing the Effectiveness of an Intervention in Irritative Contact Dermatitis:Randomized Controlled Trial
1 other identifier
interventional
25
1 country
1
Brief Summary
An eczematous reaction is an inflammatory intolerance response of the skin. In acute phase the reaction is characterized by erythema and blistering while in the chronic phase it presents as dryness, itchiness and lichenification. Irritative contact dermatitis describes these patterns of reaction in response to toxicity of chemicals on the skin cells, which trigger inflammation by activation of the innate immune system.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Jun 2023
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
June 1, 2023
CompletedFirst Submitted
Initial submission to the registry
September 13, 2023
CompletedFirst Posted
Study publicly available on registry
January 3, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2024
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2024
CompletedJanuary 3, 2024
December 1, 2023
1 year
September 13, 2023
December 18, 2023
Conditions
Outcome Measures
Primary Outcomes (3)
TEWL measurement with Khazaka probe
Transepidermal water loss
through study completion, an average of 1 year
hydration measurement with corneometer probe
corneometer assessed stratum corneum hydration level
through study completion, an average of 1 year
erythema measured with mexameter
mexameter assessed redness
through study completion, an average of 1 year
Secondary Outcomes (1)
clinical score according to dermatologist scale
through study completion, an average of 1 year
Study Arms (2)
experimental arm
EXPERIMENTALSLS irritation model and Treatment
placebo comparator
PLACEBO COMPARATORSLS irritation model and No Treatment
Interventions
Eligibility Criteria
You may qualify if:
- healthy volunteers who gave written informed consent
You may not qualify if:
- · skin cancer
- skin disease
- skin damage on measurement sites
- use of drugs that may cause photosensitivity
- non-adherence to the trial protocol
- exposure to artificial and excessive natural ultraviolet (UV) radiation
- pregnancy and lactation
- history of vitiligo, melasma and other pigmentation and photosensitivity disorders
- immunosuppression
- allergic or irritant reactions to the constituents of the cream
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
School of Medicine
Split, 21000, Croatia
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
josipa bukic
University of Split, School of Medicine
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- OTHER
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- assistant professor
Study Record Dates
First Submitted
September 13, 2023
First Posted
January 3, 2024
Study Start
June 1, 2023
Primary Completion
June 1, 2024
Study Completion
June 1, 2024
Last Updated
January 3, 2024
Record last verified: 2023-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- ICF, CSR
- Time Frame
- On request
- Access Criteria
- On request
On request