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A Study to Determine the Safety and Sensitizing Potential of HAT1 Topical Products Using Skin Sensitivity Patch Tests

NCT03406117 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 182

Last updated 2018-11-06

No results posted yet for this study

Summary

The objective of this clinical study is to assess the irritation and sensitisation potential of HAT1 topical products after repeated patch applications to healthy human participants by following conventional Repeated Insult (HRIPT), Cumulative Irritation (CIT), and Phototoxicity (PT) methodologies under the supervision of dermatologists.

Conditions

Interventions

DRUG

HAT1

All the participants will have the test product applied to the appropriate test sites by trained study staff. The study was conducted on a mixed population comprising of normal subjects, and patients with atopic dermatitis and active plaque psoriasis.

OTHER

Saline Solution

Only for CIT portion of the study. Participant will have product applied topically on site by the trained study staff.

Sponsors & Collaborators

  • Haus Bioceuticals

    lead INDUSTRY

Principal Investigators

  • P Alex, M.D. · Study Director

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2016-04-01
Primary Completion
2016-06-26
Completion
2016-07-21
FDA Drug
Yes

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03406117 on ClinicalTrials.gov