Psoriasis VulgarisPhase 2NCT01022502
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
A Phase 2 study testing refined indigo naturalis ointment and crude indigo naturalis ointment in people with Psoriasis Vulgaris, run by Yin-ku Lin at 1 site in Taiwan.
Trial summary
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis. 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?
- refined indigo naturalis ointment and crude indigo naturalis ointment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 38 participants
- Where
- 1 siteTaiwan
- Study dates
- Nov 2009to Dec 2010
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
- Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
- Patients were in good general health.
- Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
Who cannot join
- Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
- Patients had a history of allergy to indigo naturalis.
- Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
- Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
Read the detailed description
Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.
To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.
- Conditions
- Psoriasis Vulgaris
- Being tested
- refined indigo naturalis ointment, crude indigo naturalis ointment
- Keywords
- psoriasis, indigo naturalis
- Medical subject headings
- Psoriasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
refined indigo naturalis ointmentDrug
Also called refined ointment
The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
crude indigo naturalis ointmentDrug
Also called Crude ointment
The patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks.
| Study group | Role | What they receive |
|---|---|---|
| refined indigo naturalis ointment | Active comparator | Refined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study Receives: Drug: refined indigo naturalis ointment |
| crude indigo naturalis ointment | Active comparator | Crude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study Receives: Drug: crude indigo naturalis ointment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.
Measured: Baseline and Week 8
Clearing Percentage of Target Plaque Area
The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.
Measured: Baseline and Week 8
Percentage Improvement Compared to Baseline in the Target Plaque.
The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.
Measured: Baseline and Week 8
Secondary outcomes (2)
Patients' Rating of the Overall Improvement at Week 8
At week 8, patients rated an overall response to treatment (separately for each side of the body), taking into account both the extent and the degree of the disease, compared with the pretreatment condition, on a 6-point scale (0=worse,1=poor, 2=fair, 3=good, 4=excellent, 5=cleared). A score of 4 or higher represents a better outcome.
Measured: Baseline and Week 8
Patients Preferred Ointment Type.
At the end of the trial, the patients were asked which ointment they preferred.
Measured: Week 8
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2009 (estimated)
- Study startNov 2009
- Primary completionDec 2010
- Study completionDec 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Psoriasis VulgarisStudies of the same condition, open and under way.
- 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
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yin-ku Lin
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Yin-ku Lin, Chang Gung Memorial Hospital
- Investigators
- Yin-Ku Lin, MD. PhD., Principal investigator, Chang Gung Memorial Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01022502
- Sponsor's protocol ID
- CMRPG280391
- Status last verified
- Sep 2012
- First submitted
- 25 Nov 2009
- Last updated
- 16 Oct 2012
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris
- ClinicalTrials.gov ID
- NCT01022502
- Acronym / sponsor ID
- CMRPG280391
- Conditions
- Psoriasis Vulgaris
- Keywords
- psoriasis, indigo naturalis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- Yin-ku LinUniversity, hospital or other
- Study start
- Nov 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- Dec 2010 (actual)
- First posted
- 1 Dec 2009 (estimated)
- Results
- Posted 16 Oct 2012
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
Detailed description
Our previous studies have shown that topical application of indigo naturalis significantly improves psoriatic symptoms. However, patient compliance is hindered because the preparation is unsightly and stains clothing.
To improve patient compliance, we have developed a refined formulation in which closer to natural skin tones and less prone to stain clothing. In this study, we evaluated the efficacy and safety of this refined form of oil extract ointment and compared the results with those of the original crude form of indigo naturalis ointment in treating psoriasis.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| refined indigo naturalis ointment | Active comparator | Drug: refined indigo naturalis ointmentRefined indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study |
| crude indigo naturalis ointment | Active comparator | Drug: crude indigo naturalis ointmentCrude indigo naturalis ointment was applied topically to one of 2 bilaterally symmetrical psoriatic plaque lesions of the same patient for 8 weeks, starting on the date of enrollment in the study |
Who may qualify
- Ages
- 20 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients were had received a diagnosis of plaque psoriasis based on clinical assessment by two dermatologists at least a one year prior to entry into the study;
- Patients had mild to moderate plaque psoriasis with bilateral symmetric lesions; were adults aged 20 to 65 years;
- Patients were in good general health.
- Female patients of childbearing age agreed to continue using birth control measures for the duration of the study.
Key exclusion criteria (4 listed)
- Patients had non-plaque (i.e., pustular, guttate, or erythrodermic) or drug-induced forms of psoriasis; total body surface involvement of more than 60%;
- Patients had a history of allergy to indigo naturalis.
- Patients were excluded if they have received systemic therapy within 4 weeks before enrollment, phototherapy within 3 weeks, or used topical psoriasis agents within 2 weeks before enrollment.
- Patients had included usage of medications that affect psoriasis during the study and unwillingness to comply with study protocol.
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 |
|---|---|---|
| refined indigo naturalis ointmentAlso: refined ointmentThe patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. | Drug | refined indigo naturalis ointment |
| crude indigo naturalis ointmentAlso: Crude ointmentThe patients applied either refined oil extract or crude indigo naturalis ointmnet topically to each of two bilaterally symmetrical psoriatic plaque lesions for 8 weeks. | Drug | crude indigo naturalis ointment |
Primary outcome
Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8.
Time frame: Baseline and Week 8
The PSI score is comprised of the grading for scaling, erythema, and induration on a 5-point scale (where 0=absent, 1=mild, 2=moderate, 3=severe and 4=very severe) and the sum of these three items with a minimal score of 0 and a maximum of score of 12. Higher values represent a worse outcome. For expample, a highter PSI score at baseline and lower PSI score after treatment represent an improvement.
Clearing Percentage of Target Plaque Area
Time frame: Baseline and Week 8
The target plaque area was rated from 0% to 100% (0%=clearance after treatment and 100%=baseline before treatment). Higher values represent a worse outcome. For expample, a lower percentage after treatment represent an improvement.
Percentage Improvement Compared to Baseline in the Target Plaque.
Time frame: Baseline and Week 8
The improvement percentage of the target plaque at the follow-up visit was calculated as: [(Area of baseline plaque*PSI of baseline plaque - Area of plaque week 8*PSI of plaque week 8)/(Area of baseline plaque*PSI of baseline plaque)]*100%. Higher values represent a better outcome. For expample, a higher percent represents an improvement.
2 secondary outcomes
Patients' Rating of the Overall Improvement at Week 8
Time frame: Baseline and Week 8
Patients Preferred Ointment Type.
Time frame: Week 8
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2012.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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
Chang Gung Memorial Hospital
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 refined indigo naturalis ointment and crude indigo naturalis ointment in people with Psoriasis Vulgaris, run by Yin-ku Lin 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 4 inclusion and 4 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 16 Oct 2012. 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?
Yes. Results are posted in the registry (first posted 16 Oct 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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 Psoriasis Severity Idex(PSI) at Week 8. (time frame: Baseline and Week 8). The study lists 3 primary outcomes in all. 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 16 Oct 2012.