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PsoriasisPhase 2NCT01901705

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

A Phase 2 study testing Indigo naturalis ointment in people with Psoriasis, run by China Medical University Hospital at 1 site in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 20 to 65 years
Conditions the study is for
Psoriasis
What is being tested?
Indigo naturalis ointment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
24 participants
Where
1 siteTaiwan
Study dates
Feb 2013to Jan 2014
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 20 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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
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  • 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.

Trial locations and contacts

1 site in 1 country.

Taiwan1 site

  • China Medical University Hospital,

    Taichung

Other trials in Taiwan

About this study

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.

Read the 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.

Conditions
Psoriasis
Being tested
Indigo naturalis ointment, Placebo
Keywords
Psoriasis, Indigo Naturalis, chinese medicine
Medical subject headings
Psoriasis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indigo naturalis ointmentDrug

    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)

  • PlaceboDrug

    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.

Study groups in NCT01901705
Study groupRoleWhat they receive
IndigoActive comparatorThe 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.
Receives: Drug: Indigo naturalis ointment
PlaceboPlacebo comparatorThe Placebo will be provided and patients are instructed to use it twice daily for 8 weeks or achieve completely skin clearing whichever comes first.
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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)

    1. *
    2. Mild overall plaque elevation, scaling and/or erythema of the target plaque
    3. *
    4. Moderate overall plaque elevation, scaling and/or erythema of the target plaque
    5. *
    6. Severe overall plaque elevation, scaling and/or erythema of the target plaque
    7. *
    8. 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

    Measured: Baseline and at 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted17 Jul 2013 (estimated)
  2. Study startFeb 2013
  3. Primary completionJan 2014
  4. Study completionJan 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
24 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01901705
Sponsor's protocol ID
DMR101-IRB1-261
Other IDs
DMR101-IRB1-261
Status last verified
Feb 2017
First submitted
9 May 2013
Last updated
6 Feb 2017
Results posted
No
Data monitoring committee
Yes

Publications

  • 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.

    PubMed 28865459

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indigo naturalis ointment in people with Psoriasis, run by China Medical University Hospital at 1 site in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 6 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change from baseline in Overall Target Plaque Severity Score at 8 weeks (time frame: Baseline and at 8 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01901705, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Feb 2017.

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