Psoriasis VulgarisNCT01735864
Dosage Determination Trial for Indigo Naturalis Extract in Oil Ointment
A study testing Indirubin 200μg/g, Indirubin 100 μg/g and Indirubin 50 μg/g in people with Psoriasis Vulgaris, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.
Trial summary
The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing… Read more about this study
- Who is it for?
- Ages 20 to 65 years
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Indirubin 200μg/g, Indirubin 100 μg/g and Indirubin 50 μg/g
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 3 sitesTaiwan
- Study dates
- Nov 2012to Apr 2014
- Phase
- Interventional
- 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
- Aged 20 - 65 years, men or women.
- Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
- Plaque psoriasis involving <20% of BSA and with PASI <20.
- Female patients of child-bearing age with negative pregnancy test at screening.
- Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
- Willingness to comply with study protocol.
- With signed informed consent form.
Who cannot join
- With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
- With history of sensitivity to Chinese herb.
- Received systematic treatment for psoriasis within 4 weeks.
- Received topical treatment for psoriasis within 2 weeks.
- With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
- Patients with pustular or erythrodermic psoriasis.
Trial locations and contacts
3 sites in 1 country.
Taiwan3 sites
Chang Gung Memorial Hospital at Keelung
Keelung
Chang Gung Memorial Hospital at Taipei
Taipei, 105
Chang Gung Memorial Hospital at Linkou
Taoyuan City
About this study
Official title: Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination
The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.
Read the detailed description
The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.
We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.
This is a double-blind, 4-arm parallel study. The aim of this study is
- To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.
- To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.
- To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.
- To investigate the effects of INEO ointment on the immune system.
- To evaluate the effects of INEO ointment in improving quality of life after treatment.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Indirubin 200μg/g, Indirubin 100 μg/g, Indirubin 50 μg/g, Indirubin 10 μg/g
- Keywords
- Indigo naturalis extract in oil
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indirubin 200μg/gDrug
Also called INEO ointment: Indirubin 200 μg/g
- Dosage form: Ointment
- Dose(s): Each gram of ointment containing 200 μg of indirubin
- Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily
Indirubin 100 μg/gDrug
Also called INEO ointment: Indirubin 100 μg/g
- Dosage form: Ointment
- Dose(s): Each gram of ointment contains 100 μg of indirubin
- Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily
Indirubin 50 μg/gDrug
Also called INEO ointment: Indirubin 50 μg/g
- Dosage form: Ointment
- Dose(s): Each gram of ointment contains 50 μg of indirubin
- Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily
Indirubin 10 μg/gDrug
Also called INEO ointment: Indirubin 10 μg/g
- Dosage form: Ointment
- Dose(s): Each gram of ointment contains 10 μg of indirubin
- Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily
| Study group | Role | What they receive |
|---|---|---|
| Indirubin 200 μg/g | Active comparator | per gram of ointment contains 200 μg of indirubin Receives: Drug: Indirubin 200μg/g |
| Indirubin 100 μg/g | Active comparator | per gram of ointment contains 100 μg of indirubin Receives: Drug: Indirubin 100 μg/g |
| Indirubin 50 μg/g | Active comparator | per gram of ointment contains 50 μg of indirubin Receives: Drug: Indirubin 50 μg/g |
| Indirubin 10 μg/g | Active comparator | per gram of ointment contains 10 μg of indirubin Receives: Drug: Indirubin 10 μg/g |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
- Mean change of total score (range 0-72)
- Percentage change of PASI
- Individual scores of scaling, erythema, and elevation by sites
- Percentage of responder (>50% of improvement, defined as clinical meaningful) and non-responder (less then 50% of improvement)
- Percentage of subjects achieving "clear or almost clear" (defined as PASI >90% of improvement)
Measured: 8 weeks
Secondary outcomes (7)
Body surface area (BSA)involved
- Compare the BSA involved change from baseline on target psoriatic lesion(cm2)
- Compare the percentage change from baseline on target psoriatic lesion
Measured: 8 weeks
Psoriasis Severity Index (PSI)
- Mean change of total score (range 0-12) of the target psoriatic plaque
- Percentage change of PSI score of the target psoriatic plaque
- Clearing percentage of target psoriatic plaque (the target plaque before treatment is defined as 100%, and the clearance of lesion is defined as 0%)
Measured: 8 weeks
Efficacy in various local skin signs
- Thickness: thin (<0.05 mm), intermediate (≥0.05 to <1.0 mm) or thick (≥1.0 mm)
- Size: small (<5 cm in diameter), large (>5 cm in diameter) or concurrent (i.e., two type sizes exist)
- Erythema (redness): light red (ruddier (light red) than peripheral normal skin) or dark red (redder (scarlet) than peripheral normal skin)
Measured: 8 weeks
Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:
- Blood-heat (血熱) syndrome
- Blood-dryness (血燥) syndrome
- Blood-stasis (血瘀) syndrome
Measured: 8 weeks
Physician's Global Assessment (PGA)
0 = no sign of psoriasis, 1 = almost clear, 2 = mild, 3 = moderate, 4 = moderate to severe, and 5 = severe
Measured: 8 weeks
Subject's Global Assessment (SGA)
0 = cleared, 1 = excellent, 2 = good, 3 = fair, 4 = poor, and 5 = worse
Measured: 8 weeks
Dermatology Life Quality Index (DLQI) questionnaire
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Nov 2012 (estimated)
- Study startNov 2012
- Primary completionApr 2014
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- More trials run by Chang Gung Memorial HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chang Gung Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Responsible party
- Principal investigator, Yin-ku Lin, Chang Gung Memorial Hospital
- Investigators
- Yin-Ku Lin, MD., PhD., Principal investigator, Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01735864
- Sponsor's protocol ID
- NSC101-2325-B-182-018
- Status last verified
- Jul 2019
- First submitted
- 26 Nov 2012
- Last updated
- 25 Jul 2019
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 25 Jul 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Efficacy and Safety of Indigo Naturalis Extract in Oil in the Topical Therapy of Psoriasis Vulgaris: Dosage Determination
- ClinicalTrials.gov ID
- NCT01735864
- Acronym / sponsor ID
- NSC101-2325-B-182-018
- Conditions
- Psoriasis Vulgaris
- Keywords
- Indigo naturalis extract in oil
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2012
- Primary completion
- Apr 2014 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 28 Nov 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The use of refined indigo naturalis (indigo naturalis extract in oil, INEO)ointment to treat psoriasis has been proven effective in our previous study. This study aims to evaluate the efficacy and safety of INEO ointment, and further determine the optimal concentration of INEO ointment (per gram of ointment containing either 200 μg, 100 μg, 50 μg or 10 μg of indirubin) in treatment of various local skin signs and thickness of psoriasis plaque.
Detailed description
The use of indigo naturalis ointment to treat psoriasis has been proven effective in our previous clinical studies which demonstrated the efficacy and safety of topical indigo naturalis ointment, showing its ability to provide significant improvement of psoriatic skin lesions.
We developed a new formulation in which indigo naturalis powder is refined and reduces the blue discoloration of skin and clothes, making the treatment more user-friendly. We had observed an equivalent efficacy of the refined form of indigo naturalis (INEO) ointment on treating psoriasis as the crude form. However, it is necessary to determine an appropriate dosage of the refined form regarding its efficacy and safety.
This is a double-blind, 4-arm parallel study. The aim of this study is
- To determine an appropriate dosage of indirubin in INEO ointment, regarding its efficacy and safety.
- To evaluate the efficacy of INEO ointment in different local skin signs of plaque lesions.
- To evaluate the efficacy of INEO in different traditional Chinese medicine clinical syndromes of psoriasis vulgaris.
- To investigate the effects of INEO ointment on the immune system.
- To evaluate the effects of INEO ointment in improving quality of life after treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Indirubin 200 μg/g | Active comparator | Drug: Indirubin 200μg/gper gram of ointment contains 200 μg of indirubin |
| Indirubin 100 μg/g | Active comparator | Drug: Indirubin 100 μg/gper gram of ointment contains 100 μg of indirubin |
| Indirubin 50 μg/g | Active comparator | Drug: Indirubin 50 μg/gper gram of ointment contains 50 μg of indirubin |
| Indirubin 10 μg/g | Active comparator | Drug: Indirubin 10 μg/gper gram of ointment contains 10 μg of indirubin |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Aged 20 - 65 years, men or women.
- Diagnosed as mild to moderate plaque-type psoriasis by the dermatologist, with psoriasis for a minimum of 1 year.
- Plaque psoriasis involving <20% of BSA and with PASI <20.
- Female patients of child-bearing age with negative pregnancy test at screening.
- Female patients of childbearing age who have agreed to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
Key exclusion criteria (6 listed)
- With history of topically or systematically hypersensitive to indigo naturalis or its excipient in ointment.
- With history of sensitivity to Chinese herb.
- Received systematic treatment for psoriasis within 4 weeks.
- Received topical treatment for psoriasis within 2 weeks.
- With abnormal liver or renal function, clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome,psychiatric disease, cancer or AIDS.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Indirubin 200μg/gAlso: INEO ointment: Indirubin 200 μg/g1. Dosage form: Ointment 2. Dose(s): Each gram of ointment containing 200 μg of indirubin 3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily | Drug | Indirubin 200 μg/g |
| Indirubin 100 μg/gAlso: INEO ointment: Indirubin 100 μg/g1. Dosage form: Ointment 2. Dose(s): Each gram of ointment contains 100 μg of indirubin 3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily | Drug | Indirubin 100 μg/g |
| Indirubin 50 μg/gAlso: INEO ointment: Indirubin 50 μg/g1. Dosage form: Ointment 2. Dose(s): Each gram of ointment contains 50 μg of indirubin 3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily | Drug | Indirubin 50 μg/g |
| Indirubin 10 μg/gAlso: INEO ointment: Indirubin 10 μg/g1. Dosage form: Ointment 2. Dose(s): Each gram of ointment contains 10 μg of indirubin 3. Dosing schedule: apply 0.5 g of ointment per 10 x 10 cm psoriatic lesion twice daily | Drug | Indirubin 10 μg/g |
Primary outcome
Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups
Time frame: 8 weeks
1. Mean change of total score (range 0-72) 2. Percentage change of PASI 3. Individual scores of scaling, erythema, and elevation by sites 4. Percentage of responder (>50% of improvement, defined as clinical meaningful) and non-responder (less then 50% of improvement) 5. Percentage of subjects achieving "clear or almost clear" (defined as PASI >90% of improvement)
7 secondary outcomes
Body surface area (BSA)involved
Time frame: 8 weeks
Psoriasis Severity Index (PSI)
Time frame: 8 weeks
Efficacy in various local skin signs
Time frame: 8 weeks
Efficacy in different traditional Chinese medicine (TCM) clinical syndromes of psoriasis by PASI/PSI:
Time frame: 8 weeks
Physician's Global Assessment (PGA)
Time frame: 8 weeks
Subject's Global Assessment (SGA)
Time frame: 8 weeks
Dermatology Life Quality Index (DLQI) questionnaire
Time frame: 8 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jul 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yin-Ku Lin, MD., PhD. principal investigator
Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Indirubin 200μg/g, Indirubin 100 μg/g and Indirubin 50 μg/g in people with Psoriasis Vulgaris, run by Chang Gung Memorial Hospital at 3 sites 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 7 inclusion and 6 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 25 Jul 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
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?
Compare the mean percentage change of Psoriasis Areas Severity Index (PASI) from baseline at week 8 between groups (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Jul 2019.