Psoriasis Vulgaris
Conditions
Keywords
psoriasis, indigo naturalis
Brief summary
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.
Interventions
DRUGrefined indigo naturalis 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.
DRUGcrude indigo naturalis 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.
Sponsors
Yin-ku Lin
Study design
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
20 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
* 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.
Exclusion criteria
* 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | 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 | 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. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Patients' Rating of the Overall Improvement at Week 8 | Baseline and 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. |
| Patients Preferred Ointment Type. | Week 8 | At the end of the trial, the patients were asked which ointment they preferred. |
Countries
Taiwan
Participant flow
Recruitment details
Participants recruited from ambulatory department of Chang Gung Memorial Hospital,in northern Taiwan between November 2009 and May 2010.
Pre-assignment details
41 participants recruited and screened,3 exclude ( 2 did not meet the eligibility criteria and 1 refuesed to participate).
Participants by arm
| Arm | Count |
|---|---|
| All Participants (Refined/Crude Ointment) Two symmetrically comparable plaques on each participant were identified, one randomly assigned to receive refined ointment, and the other assigned to receive crude ointment. Photographs of the lesions were taken and lesion severity was evaluated at baseline and at week 2, 4, 6, and 8. | 38 |
| Total | 38 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 1 |
| Overall Study | employment related reasons | 1 |
| Overall Study | Withdrawal by Subject | 1 |
Baseline characteristics
| Characteristic | All Participants (Refined/Crude Ointment) |
|---|---|
| Age Continuous | 42.8 years STANDARD_DEVIATION 12.7 |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 31 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 3 / 38 | 1 / 38 |
| serious Total, serious adverse events | 0 / 38 | 0 / 38 |
Outcome results
Primary
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.
Time frame: Baseline and Week 8
Population: Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared PSI scores between the two lesions and before treatment with those after treatment.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Crude Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Scaling | -2.0 units on a scale | 95% Confidence Interval 0.9 |
| Crude Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Erythema | -1.7 units on a scale | 95% Confidence Interval 0.85 |
| Crude Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Induration | -1.9 units on a scale | 95% Confidence Interval 0.82 |
| Crude Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | PSI score | -5.7 units on a scale | 95% Confidence Interval 2.34 |
| Refined Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | PSI score | -6.0 units on a scale | 95% Confidence Interval 2.3 |
| Refined Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Scaling | -2.1 units on a scale | 95% Confidence Interval 0.87 |
| Refined Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Induration | -2.0 units on a scale | 95% Confidence Interval 0.84 |
| Refined Indigo Naturalis Ointment | Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. | Erythema | -2.0 units on a scale | 95% Confidence Interval 0.8 |
Primary
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.
Time frame: Baseline and Week 8
Population: Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared clearing percent of target plaque between the two lesions and before treatment with those after treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Crude Indigo Naturalis Ointment | Clearing Percentage of Target Plaque Area | 38.85 percentage of the target area |
| Refined Indigo Naturalis Ointment | Clearing Percentage of Target Plaque Area | 40.97 percentage of the target area |
Primary
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.
Time frame: Baseline and Week 8
Population: Total number of participants completing the 8 week period with study intervention. The paired t-test was used to compared percent of improvement related to baseline between the two lesions and before treatment with those after treatment.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Crude Indigo Naturalis Ointment | Percentage Improvement Compared to Baseline in the Target Plaque. | 74.80 percent change of target plaque |
| Refined Indigo Naturalis Ointment | Percentage Improvement Compared to Baseline in the Target Plaque. | 74.28 percent change of target plaque |
Secondary
Patients Preferred Ointment Type.
At the end of the trial, the patients were asked which ointment they preferred.
Time frame: Week 8
Population: Total number of participants completing the 8 week period with study intervention.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crude Indigo Naturalis Ointment | Patients Preferred Ointment Type. | 1 participants |
| Refined Indigo Naturalis Ointment | Patients Preferred Ointment Type. | 31 participants |
Secondary
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.
Time frame: Baseline and Week 8
Population: Total number of participants completing the 8 week period with study intervention and who reported excellent or cleared at week 8 were used for analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Crude Indigo Naturalis Ointment | Patients' Rating of the Overall Improvement at Week 8 | 21 participants |
| Refined Indigo Naturalis Ointment | Patients' Rating of the Overall Improvement at Week 8 | 23 participants |