Microbial Colonization and Change of Chronic Keratinized Hand Eczema After Using Halometasone Triclosan

NCT03246776 | Completed Phase 4

• 1 other identifier: BeijingFH20170801
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

The clinical study of the microbial colonization of chronic keratinized hand eczema and the change of microbial colonization after external using of Halometasone Triclosan Cream

Conditions

Chronic Hand Eczema

Outcome Measures

Primary Outcomes (1)

• Response to Hand eczema severity

  HEES(hand eczema extent score)

  2 weeks

Secondary Outcomes (7)

• Response to treatment/Hand eczema severity

  2 weeks

• Investigator reported improvement

  2 weeks

• Response to treatment/Hand eczema severity

  2 weeks

• Response to Quality of Life

  week 0 and 2

• Patient Reported Improvement

  up to 2 weeks

Study Arms (1)

Halometasone Triclosan Cream

EXPERIMENTAL

All subjects receive external Use of Halometasone Triclosan Cream

Drug: Halometasone Triclosan

Interventions

Halometasone Triclosan DRUG

Halometasone Triclosan . The study product will be applied topically twice a day (morning and evening) for 14 days of treatment

Also known as: regular moisturizer, wet wrap bandage

Halometasone Triclosan Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 18 years
• Chronic Keratinized hand eczema for at least 3 months
• The affected area is greater than 30%
• Overall assessment of the severity of the disease(IGA)≥3 OR HEES≥13
• No obvious incentive .Who have read the instructions of the subject, agreed to and signed written informed consent, and have been able to provide a personal medical history.

You may not qualify if:

• Pregnancy, breast feeding
• Severe liver and kidney disease, blood system disease, autoimmune disease, chronic severe infection, diabetes, mental illness, drug use, alcohol abuse, etc
• Malignant neoplasms or other serious maladies that may affect the correct assessment of efficacy
• Topical corticosteroid was suspended for less than 2 weeks;The system used corticosteroids and other immunosuppressive agents (thunder vine and other drugs) which were suspended for less than four weeks
• Eczema of the facial and skin creases
• Atopic dermatitis, contact dermatitis, blister hand eczema, contact urticaria, discoid eczema
• participated in other clinical trials within 3 months.
• Known sensitivity to Halometasone Triclosan
• failure to follow the prescribed medication or the incomplete record of the test process which will affect the curative effect judgment
• Other reasons why researchers think they should not be included

Sponsors & Collaborators

• Beijing Friendship Hospital: lead

Study Sites (1)

Friendship Hospital

Beijing, Beijing Municipality, 100000, China

Location

Study Officials

• linfeng li, phd

  Beijing Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Masking Details: open label
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: associated professor

Study Record Dates

• First Submitted: August 2, 2017
• First Posted: August 11, 2017
• Study Start: August 20, 2017
• Primary Completion: December 8, 2017
• Study Completion: December 8, 2017
• Last Updated: January 29, 2018

Record last verified: 2018-01

Locations

CN (1)