Psoriasis VulgarisPhase 2NCT02088281
Mechanistic Study of Indigo Naturalis in Treating Psoriasis
A Phase 2 study testing Indigo naturalis extract in oil ointment in people with Psoriasis Vulgaris, run by Chang Gung Memorial Hospital at 1 site in Taiwan.
Trial summary
The potential effect of indigo naturalis on the immune system is unknown. The investigators hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis… Read more about this study
- Who is it for?
- Ages 20 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Psoriasis Vulgaris
- What is being tested?
- Indigo naturalis extract in oil ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2012to Jul 2013
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Aged 20 - 65 years, men or women
- Diagnosed as plaque-type psoriasis by the dermatologist.
- Plaque psoriasis involving <20% of the body surface area (BSA) and the psoriasis area and severity index (PASI) <20
- If of child-bearing age, negative pregnancy test at screening, agreement to continue using birth control measures approved by the investigator for the duration of the study.
- Willingness to comply with study protocol and signed informed consent form.
Who cannot join
- A history of topically or systematically sensitivity to indigo naturalis or any component in excipient.
- Systematic therapy for psoriasis within 4 weeks of baseline including Methotrexate (MTX), immunosuppressive agents (e.g. cyclosporine), retinoid (vitamin A derivatives), biologics (e.g. Etanercept, Alefacept, Infliximab), vitamin D3 analogs and phototherapy.
- Topical therapy for psoriasis within 2 weeks of baseline including tar, corticosteroid, vitamin D3 analogs, retinoid.
- Pustular or generalized erythrodermic psoriasis.
- With abnormal liver or renal function (e.g. liver cirrhosis, hepatitis B/C, renal failure, creatinine >2.0 mg/dL, AST/ALT >3 x ULN), clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
- Women who are lactating, are pregnant or are planning to become pregnant.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Mechanistic Study of Indigo Naturalis in Treating Psoriasis: Local or Systemic Manipulation of Inflammation and Induction of Immunoregulation
The potential effect of indigo naturalis on the immune system is unknown. The investigators hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
Read the detailed description
Psoriasis is a chronic inflammatory dermatosis induced by altered interactions between the immune system and skin and characterized by hyperplasia of the epidermis (acanthosis), infiltration of leukocytes into both the dermis and epidermis, and dilation and growth of blood vessels. Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms and demonstrated that the anti-psoriatic effects of indigo naturalis are mediated by promoting differentiation and inhibiting proliferation of epidermal keratinocytes. However, the potential effect of indigo naturalis on the immune system is unknown.
Currently, growing evidence demonstrates that activated T cells are the primary modulators in the pathogenesis of psoriasis and psoriasis is believed to be a mixed Th1/Th17 disease with strong IL-17 and interferon-γ (IFN-γ) signatures. The identification of elevated levels of IFN-γ, tumor necrosis factor (TNF-α), IL-12, IL-17 and IL 22 in cutaneous lesions and in the serum of psoriatic patients supports the theory that these Th1/Th17-related cytokines directly or indirectly act on keratinocytes leading to their activation and hyperproliferation. The investigators suppose the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
The aim of this study is:
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the function of Th1/Th17 cells expressing IFN-γ and IL-17 in peripheral blood of patients with psoriasis before and after therapy.
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the production of pro-inflammatory cytokines in peripheral blood of patients with psoriasis before and after therapy.
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with histopathological change in psoriatic lesions and whether these pathological changes are different from the change in inflammatory and immune reactions in patients with psoriasis.
- To investigate the effects of Th1/Th17-related cytokines and immunological factors in patients with indigo naturalis treatment on epidermal keratinocytes.
- To detect the effect of indigo naturalis on the function of releasing cytokines (IFN-γ, IL-17, and IL-23, etc.) from monocytes in patients with psoriasis.
- To analyze the concentration of indirubin in peripheral blood and to clarify whether the effect of indigo naturalis in improving psoriatic symptoms is: (A) a systemic effect that affects the metabolism and immune system through absorption and transdermal delivery into body. (B) a direct effect on the epidermal keratinocytes alone.
- Conditions
- Psoriasis Vulgaris
- Being tested
- Indigo naturalis extract in oil ointment
- Keywords
- Indigo naturalis, indirubin, Th1 cells, Th17 cells
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Indigo naturalis extract in oil ointmentDrug
Also called INEO ointment
Apply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily.
| Study group | Role | What they receive |
|---|---|---|
| Indigo naturalis extract in oil ointment | Experimental | Indigo naturalis extract in oil ointment: each gram of ointment contains 200 μg±20 μg of indirubin. Receives: Drug: Indigo naturalis extract in oil ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change of psoriasis severity compared to the change of Th1/ Th17 related cytokines from the peripheral blood
The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compared to the change in the Th1/ Th17 related cytokines in peripheral blood.
Measured: 8 weeks
Secondary outcomes (2)
The relationship of the change in psoriasis severity and the associated change of the concentration of indirubin from the peripheral blood.
The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compare to the concentration of indirubin in the peripheral blood.
Measured: 8 weeks
The relationship of the change in psoriasis severity and the associated change in the Th1/ Th17 related cytokines from the target psoriatic lesion.
The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compared to the local immune response (the change of the histopathology from baseline to week 8).
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 posted14 Mar 2014 (estimated)
- Study startNov 2012
- Primary completionJul 2013
- Study completionJul 2013
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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 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
- Sponsor
- Investigators
- YIn-Ku Lin, MD., PhD., Principal investigator, Department Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02088281
- Sponsor's protocol ID
- NSC 101-2320-B-182-021-MY3
- Status last verified
- Oct 2012
- First submitted
- 10 Dec 2012
- Last updated
- 14 Mar 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanistic Study of Indigo Naturalis in Treating Psoriasis: Local or Systemic Manipulation of Inflammation and Induction of Immunoregulation
- ClinicalTrials.gov ID
- NCT02088281
- Acronym / sponsor ID
- NSC 101-2320-B-182-021-MY3
- Conditions
- Psoriasis Vulgaris
- Keywords
- Indigo naturalis, indirubin, Th1 cells, Th17 cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Chang Gung Memorial HospitalUniversity, hospital or other
- Collaborators
- National Science and Technology Council, Taiwan
- Study start
- Nov 2012
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 14 Mar 2014 (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 potential effect of indigo naturalis on the immune system is unknown. The investigators hypothesize that the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
Detailed description
Psoriasis is a chronic inflammatory dermatosis induced by altered interactions between the immune system and skin and characterized by hyperplasia of the epidermis (acanthosis), infiltration of leukocytes into both the dermis and epidermis, and dilation and growth of blood vessels. Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms and demonstrated that the anti-psoriatic effects of indigo naturalis are mediated by promoting differentiation and inhibiting proliferation of epidermal keratinocytes. However, the potential effect of indigo naturalis on the immune system is unknown.
Currently, growing evidence demonstrates that activated T cells are the primary modulators in the pathogenesis of psoriasis and psoriasis is believed to be a mixed Th1/Th17 disease with strong IL-17 and interferon-γ (IFN-γ) signatures. The identification of elevated levels of IFN-γ, tumor necrosis factor (TNF-α), IL-12, IL-17 and IL 22 in cutaneous lesions and in the serum of psoriatic patients supports the theory that these Th1/Th17-related cytokines directly or indirectly act on keratinocytes leading to their activation and hyperproliferation. The investigators suppose the therapeutic effect of indigo naturalis in psoriasis may involve inhibiting the activation of Th1 and Th17 cells that produce pro-inflammatory cytokines, thereby regulating the hyperplasia of epidermis induced by Th1/Th17 related cytokines.
The aim of this study is:
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the function of Th1/Th17 cells expressing IFN-γ and IL-17 in peripheral blood of patients with psoriasis before and after therapy.
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with the production of pro-inflammatory cytokines in peripheral blood of patients with psoriasis before and after therapy.
- To investigate whether the effect of indigo naturalis in improving psoriatic symptoms is associated with histopathological change in psoriatic lesions and whether these pathological changes are different from the change in inflammatory and immune reactions in patients with psoriasis.
- To investigate the effects of Th1/Th17-related cytokines and immunological factors in patients with indigo naturalis treatment on epidermal keratinocytes.
- To detect the effect of indigo naturalis on the function of releasing cytokines (IFN-γ, IL-17, and IL-23, etc.) from monocytes in patients with psoriasis.
- To analyze the concentration of indirubin in peripheral blood and to clarify whether the effect of indigo naturalis in improving psoriatic symptoms is: (A) a systemic effect that affects the metabolism and immune system through absorption and transdermal delivery into body. (B) a direct effect on the epidermal keratinocytes alone.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Indigo naturalis extract in oil ointment | Experimental | Drug: Indigo naturalis extract in oil ointmentIndigo naturalis extract in oil ointment: each gram of ointment contains 200 μg±20 μg of indirubin. |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Aged 20 - 65 years, men or women
- Diagnosed as plaque-type psoriasis by the dermatologist.
- Plaque psoriasis involving <20% of the body surface area (BSA) and the psoriasis area and severity index (PASI) <20
- If of child-bearing age, negative pregnancy test at screening, agreement to continue using birth control measures approved by the investigator for the duration of the study.
- Willingness to comply with study protocol and signed informed consent form.
Key exclusion criteria (6 listed)
- A history of topically or systematically sensitivity to indigo naturalis or any component in excipient.
- Systematic therapy for psoriasis within 4 weeks of baseline including Methotrexate (MTX), immunosuppressive agents (e.g. cyclosporine), retinoid (vitamin A derivatives), biologics (e.g. Etanercept, Alefacept, Infliximab), vitamin D3 analogs and phototherapy.
- Topical therapy for psoriasis within 2 weeks of baseline including tar, corticosteroid, vitamin D3 analogs, retinoid.
- Pustular or generalized erythrodermic psoriasis.
- With abnormal liver or renal function (e.g. liver cirrhosis, hepatitis B/C, renal failure, creatinine >2.0 mg/dL, AST/ALT >3 x ULN), clinically significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), 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 |
|---|---|---|
| Indigo naturalis extract in oil ointmentAlso: INEO ointmentApply 0.5 g of INEO ointment per 10 x 10 cm psoriasis lesion twice daily. | Drug | Indigo naturalis extract in oil ointment |
Primary outcome
The change of psoriasis severity compared to the change of Th1/ Th17 related cytokines from the peripheral blood
Time frame: 8 weeks
The aim of this study is to clarify the mechanism of indigo naturalis in eliminating inflammation and in regulating the immune system by way of local or systemic effect. The investigators will evaluate the clinical efficacy which includes the mean percentage change of Psoriasis Areas Severity Index (PASI) and Body Surface Area (BSA) from baseline to week 8 as compared to the change in the Th1/ Th17 related cytokines in peripheral blood.
2 secondary outcomes
The relationship of the change in psoriasis severity and the associated change of the concentration of indirubin from the peripheral blood.
Time frame: 8 weeks
The relationship of the change in psoriasis severity and the associated change in the Th1/ Th17 related cytokines from the target psoriatic lesion.
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 14 Mar 2014.
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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 Traditional Chinese Medicine, Chang Gung Memorial Hospital at Keelung
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Indigo naturalis extract in oil ointment in people with Psoriasis Vulgaris, run by Chang Gung Memorial 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 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 14 Mar 2014. 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. 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?
The change of psoriasis severity compared to the change of Th1/ Th17 related cytokines from the peripheral blood (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 14 Mar 2014.