Phase 2
Completed N=38
Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis
Source: ClinicalTrials.gov NCT01022502 ↗Enrolled (actual)
38
Serious AEs
0.0%
Results posted
Oct 2012
Primary outcomePrimary: Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. — -2.0; -2.1; -1.7; -2.0 units on a scale
Summary
To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. |
-2.0; -2.1; -1.7; -2.0; -1.9; -2.0 | — |
| PRIMARY Clearing Percentage of Target Plaque Area |
38.85; 40.97 | — |
| PRIMARY Percentage Improvement Compared to Baseline in the Target Plaque. |
74.80; 74.28 | — |
| SECONDARY Patients' Rating of the Overall Improvement at Week 8 |
21; 23 | — |
| SECONDARY Patients Preferred Ointment Type. |
1; 31 | — |
Eligibility Criteria
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.
Data sourced from ClinicalTrials.gov (NCT01022502). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.