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A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

Primary Purpose

Psoriasis

Status

Completed

Phase

Phase 2

Locations

Taiwan

Study Type

Interventional

Intervention

Indigo naturalis ointment

Placebo

About this trial

This is an interventional treatment trial for Psoriasis focused on measuring Psoriasis, Indigo Naturalis, chinese medicine

Eligibility Criteria

20 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

men or women at ages between 20 - 65 years old with at least 6 months diagnosis of moderate to mild plaque-type psoriasis who have a screening and at time of study agent treatment Psoriasis Global Assessment (PGA)=2-3, and have under 20% of their total body surface area (BSA) involved. , with a target plaque for at least 4 sq cm
In good general health, as evidenced by physical examination, and hematology and blood chemistry tests within normal ranges with the exception of liver function test value <=1.5ULN
If of childbearing age, agreement to continue using birth control measures for the duration of the study
Patients who agreed to participate and signed the consent form
Patients who agreed to return for follow-up visits and provide all required biopsies.

Exclusion Criteria:

Currently have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis), or rebound or flare of chronic plaque psoriasis
Currently or had history of psoriatic arthritis
Have current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium).
Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study.
Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer
Have received phototherapy or any systemic treatment that could affect psoriasis (including, but not limited to, (eg, retinoids, methotrexate, cyclosporine, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatment or traditional Chinese medicine) within 4 weeks of receiving study treatment
Have used topical treatment that could affect psoriasis (eg. corticosteroid tazarotene, and tacrolimus, tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, topical traditional Chinese medicines) within 2 weeks of receiving study treatment
Have used any systemic immunosuppressants (eg, MTX, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of receiving study treatment
Are currently receiving lithium, antimalarials, or intramuscular gold, or have received lithium, antimalarials, or intramuscular gold within 4 weeks of receiving study treatment
Positive screening tests for HIV, hepatitis B surface antigen, or hepatitis C antibody
A history of alcohol or other drug abuse
Clinically significant laboratory abnormality in blood, renal function, or liver function
A history of sensitivity to Chinese herbs, olive oil, yellow wax, or petroleum jelly
Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
Be participating in another trial using an investigational agent or procedure.
Any other conditions that in the view of investigator, the subject should not be enrolled.

Sites / Locations

China Medical University Hospital,

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Indigo

Placebo

Arm Description

The Indigo naturalis ointment will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.

The Placebo will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.

Outcomes

Primary Outcome Measures

Change from baseline in Overall Target Plaque Severity Score at 8 weeks

OTPSS(Overall Target Plaque Severity Score ) Score Description 0 No evidence of disease (except possible residual discoloration) * Mild overall plaque elevation, scaling and/or erythema of the target plaque * Moderate overall plaque elevation, scaling and/or erythema of the target plaque * Severe overall plaque elevation, scaling and/or erythema of the target plaque * Very severe overall plaque elevation, scaling and/or erythema of the target plaque *Grades 1, 3, 5 & 7 are midpoints between the defined grades 0, 2, 4, 6 & 8

Secondary Outcome Measures

Full Information

NCT ID

NCT01901705

First Posted

May 9, 2013

Last Updated

February 2, 2017

Sponsor

China Medical University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT01901705

Brief Title

A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

Official Title

A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

Study Type

Interventional

2. Study Status

Record Verification Date

February 2017

Overall Recruitment Status

Completed

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

China Medical University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

Psoriasis is a common, chronic skin disease for which only remissive, as opposed to curative, treatments are available. Traditional Chinese medicine is one of the most frequently chosen alternative therapies in China and Taiwan, and psoriasis has been treated for centuries with topical and oral herbal preparations. Topical indigo naturalis ointment has been reported to exhibit potential anti-psoriatic efficacy. The study objective is to investigate pharmacological effect and explore targeting mechanisms of Traditional Chinese Medicine (TCM) Indigo Naturalis topical ointment as a single treatment agent in Chinese subjects with mild to moderate plaque-type Psoriasis. This was a single site, randomized, double-blinded, placebo controlled study of topical indigo naturalis vs. vehicle alone (placebo) to treat mild to moderate plaque-type psoriasis during an 8-week period. Pharmacological effect will be evaluated by biomarker evaluation and clinical evaluation. The trial was conducted at the China Medical University Hospital (CMUH), Taichung, Taiwan. All patients provided written informed consent before inclusion in the study. The study protocol was approved by the institutional review board (IRB) of CMUH.

Detailed Description

Estimated enrollment: Total of 24 subjects: mild to moderate psoriasis patients will be randomized into treatment group (n=16) placebo group (n=8) Study evaluation: A baseline and end of the study evaluation on the patients will be performed, including physical examination, hemogram and blood biochemical analysis (including glutamic-oxaloacetic transaminase, glutamic-pyruvic transaminase, and creatinine measurement). The baseline and end of the study of total body surface area involvement and Psoriasis Area Severity Index (PASI), PGA, OTPSS scores will be also calculated.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Psoriasis

Keywords

Psoriasis, Indigo Naturalis, chinese medicine

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

24 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Indigo

Arm Type

Active Comparator

Arm Description

The Indigo naturalis ointment will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

The Placebo will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.

Intervention Type

Drug

Intervention Name(s)

Indigo naturalis ointment

Intervention Description

The Indigo naturalis ointment was composed of a 1:10 mixture of Indigo naturalis powder and a vehicle consisting of Vaseline: microcrystalline wax: olive oil (5:6:9 ratio)

Intervention Type

Drug

Intervention Name(s)

Placebo

Intervention Description

The placebo was a mixture of blue dye powder (54.8% Indigo carmine aluminum lake [Blue #32] and 45.2% Allura Red AC aluminum lake [Red #40] powders), Vaseline, microcrystalline wax, and olive oil.

Primary Outcome Measure Information:

Title

Change from baseline in Overall Target Plaque Severity Score at 8 weeks

Description

Time Frame

Baseline and at 8 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: men or women at ages between 20 - 65 years old with at least 6 months diagnosis of moderate to mild plaque-type psoriasis who have a screening and at time of study agent treatment Psoriasis Global Assessment (PGA)=2-3, and have under 20% of their total body surface area (BSA) involved. , with a target plaque for at least 4 sq cm In good general health, as evidenced by physical examination, and hematology and blood chemistry tests within normal ranges with the exception of liver function test value <=1.5ULN If of childbearing age, agreement to continue using birth control measures for the duration of the study Patients who agreed to participate and signed the consent form Patients who agreed to return for follow-up visits and provide all required biopsies. Exclusion Criteria: Currently have non-plaque forms of psoriasis (e.g., erythrodermic, guttate, or pustular psoriasis), or rebound or flare of chronic plaque psoriasis Currently or had history of psoriatic arthritis Have current drug-induced psoriasis (e.g., a new onset of psoriasis or an exacerbation of psoriasis from beta blockers, calcium channel blockers, or lithium). Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study. Have used any biologic within the previous 3 months or 5 times the half-life of the biologic, whichever is longer Have received phototherapy or any systemic treatment that could affect psoriasis (including, but not limited to, (eg, retinoids, methotrexate, cyclosporine, psoralens, sulfasalazine, hydroxyurea, fumaric acid derivatives, herbal treatment or traditional Chinese medicine) within 4 weeks of receiving study treatment Have used topical treatment that could affect psoriasis (eg. corticosteroid tazarotene, and tacrolimus, tar, anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethylpsoralens, topical traditional Chinese medicines) within 2 weeks of receiving study treatment Have used any systemic immunosuppressants (eg, MTX, azathioprine, cyclosporine, 6-thioguanine, mercaptopurine, mycophenolate mofetil, hydroxyurea, and tacrolimus) within 4 weeks of receiving study treatment Are currently receiving lithium, antimalarials, or intramuscular gold, or have received lithium, antimalarials, or intramuscular gold within 4 weeks of receiving study treatment Positive screening tests for HIV, hepatitis B surface antigen, or hepatitis C antibody A history of alcohol or other drug abuse Clinically significant laboratory abnormality in blood, renal function, or liver function A history of sensitivity to Chinese herbs, olive oil, yellow wax, or petroleum jelly Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, hematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease Be participating in another trial using an investigational agent or procedure. Any other conditions that in the view of investigator, the subject should not be enrolled.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hui man cheng

Organizational Affiliation

China Medical University Hospital

Official's Role

Principal Investigator

Facility Information:

Facility Name

China Medical University Hospital,

City

Taichung,

Country

Taiwan

12. IPD Sharing Statement

Citations:

PubMed Identifier

28865459

Citation

Cheng HM, Wu YC, Wang Q, Song M, Wu J, Chen D, Li K, Wadman E, Kao ST, Li TC, Leon F, Hayden K, Brodmerkel C, Chris Huang C. Clinical efficacy and IL-17 targeting mechanism of Indigo naturalis as a topical agent in moderate psoriasis. BMC Complement Altern Med. 2017 Sep 2;17(1):439. doi: 10.1186/s12906-017-1947-1.

Results Reference

derived

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A Study of Topical Indigo Naturalis Treatment in Patients With Mild to Moderate Plaque-type Psoriasis

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