DEC033 Study Product for Mild to Moderate Eczema An Open-label, Adaptive-design Pilot Study

NCT02379507 | Completed Phase 1

• 1 other identifier: DECI1200
• Study Type: interventional
• Target: 20
• Locations: 0 countries
• Sites: N/A

Brief Summary

This open-label, adaptive design study was designed to determine the efficacy of the study product in the treatment of eczema which would be assessed by the reduction of the appearance of skin lesions and symptoms associated such as itching, scaling and redness.

Conditions

Eczema

Keywords

mild to moderate

Outcome Measures

Primary Outcomes (1)

• Symptoms of Itching, Scaling, and Redness measured by Visual Analog Scale (VAS)

  Subjects completed the Visual Analog Scale for eczema symptoms - itching, scaling, and redness.

  30 days

Secondary Outcomes (1)

• Size and Severity of Eczema Lesions measured by Dermatologic Assessments

  30 days

Study Arms (1)

DEC033 Study Product

EXPERIMENTAL

Apply twice a day

Other: DEC033 Study Product

Interventions

DEC033 Study Product OTHER

Apply twice daily

DEC033 Study Product

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Healthy male or female ≥ 18 and ≤ 70 years of age.
• Body mass index (BMI) ≥ 20 and ≤ 35 kg/m2.
• Subjects with mild to moderate eczema; determined at screening visit.
• Judged by the Investigator to be in general good health on the basis of medical history.
• Agree to use the Study-supplied cleanser and moisturizer as the only body cosmetic applied to irritated skin.
• Agree to stop all medications and supplements during the entire length of the study
• Females of child bearing potential must agree to use appropriate birth control methods during the entire study period.
• Agree not to initiate any new exercise or diet programs during the entire study period.
• Agree not to change their current diet or exercise program during the entire study period.
• Understands the study procedures and signs forms providing informed consent to participate in the study and authorization for release of relevant protected health information to the study investigator.

You may not qualify if:

• Clinically significant renal, hepatic, endocrine (including diabetes mellitus), cardiac, pulmonary, pancreatic, neurologic, hematologic, or biliary disorder.
• Known allergy or sensitivity to Herbal products.
• History or presence of cancer in the prior two years, including any skin cancer or suspicious lesions.
• Recent history of alcoholism (within 12 months) or strong potential for alcohol or substance abuse.
• Participation in a clinical study with exposure to any non-registered drug product within 30 days prior.
• Individual has a condition the Investigator believes would interfere with his or her ability to provide informed consent, comply with the study protocol, which might confound the interpretation of the study results or put the person at undue risk. Including subjects who are Bed or wheelchair-bound.
• Pregnant, lactating, or unwilling to use adequate contraception during the duration of the study.
• Smoking - must be nonsmoker for at least 12 weeks prior to screening.

Sponsors & Collaborators

• Medicus Research, LLC: lead

MeSH Terms

Conditions

Eczema

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 13, 2015
• First Posted: March 5, 2015
• Study Start: January 1, 2014
• Primary Completion: June 1, 2014
• Study Completion: June 1, 2014
• Last Updated: March 5, 2015

Record last verified: 2015-01