Status:
COMPLETED
Efficacy and Safety of HAT1 Compared to Calcipotriol in Patients With Mild to Moderate Chronic Plaque Psoriasis
Lead Sponsor:
Haus Bioceuticals
Conditions:
Psoriasis
Eligibility:
All Genders
12-60 years
Phase:
PHASE2
Brief Summary
Psoriasis, the most prevalent autoimmune disease in the U.S., manifests with plaque type psoriasis vulgaris with lesions localized to the scalp, postauricular region, face, diaper area, elbows, and kn...
Detailed Description
This is a randomized, double-blind trial. All patients who meet entry criteria will be randomized to receive either topical HAT01 or calcipotriol to be applied to the affected area 2 times per day. Tr...
Eligibility Criteria
Inclusion
- Clinical diagnosis of active plaque psoriasis with a minimum PGA score of 2 but not greater than 4
- Males or Females between 12-60 years
- Treatment area amenable to topical treatment
- Attending a hospital outpatient clinic or the private practice of a dermatologist
- Following verbal and written information about the trial, the patient must provide signed and dated informed consent before any study related activity is carried out, including activities relating to washout period.
Exclusion
- Currently have non-plaque forms of psoriasis, eg, erythrodermic, guttate, or pustular psoriasis or a drug induced form of psoriasis.
- Systemic treatment with immunosuppressive drugs or corticosteroids within 4 weeks prior to enrollment. (Inhaled or intranasal steroids for asthma or rhinitis may be used)
- Topical treatment with immunomodulators or corticosteroids within 4 weeks prior to enrollment.
- Phototherapy treatment within 4 weeks prior to enrollment.
- Other topical therapy on the treatment area within 1 week prior to enrollment.
- Use of anti-histamine treatment during the study
- Clinical infection on the treatment area.
- Patients with history of cancer including skin cancer.
- Patients with history of an immunocompromised disease.
- Current participation in any other interventional clinical trial.
- Pregnancy or risk of pregnancy, and/or lactation
- History of allergy of any herbal components in HAT1
- Subjects with intense sun exposure during the study
- Patients known or suspected of not being able to comply with a trial protocol (e.g. alcoholism, drug dependency, or psychotic state)
Key Trial Info
Start Date :
February 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
September 5 2016
Estimated Enrollment :
174 Patients enrolled
Trial Details
Trial ID
NCT03848806
Start Date
February 29 2016
End Date
September 5 2016
Last Update
February 21 2019
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