Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis - Full Text View

Purpose

To compare the efficacy and safety of refined indigo naturalis ointment with that of crude ointment in treating psoriasis.

Condition	Intervention	Phase
Psoriasis Vulgaris	Drug: refined indigo naturalis ointment Drug: crude indigo naturalis ointment	Phase 2

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Single Blind (Outcomes Assessor) Primary Purpose: Treatment
Official Title:	Efficacy and Safety Comparison Between Refined and Crude Indigo Naturalis Ointment in the Treatment of Psoriatic Vulgaris

Resource links provided by NLM:

MedlinePlus related topics: Psoriasis

U.S. FDA Resources

Further study details as provided by Chang Gung Memorial Hospital:

Primary Outcome Measures:

Change From Baseline in Psoriasis Severity Idex(PSI) at Week 8. [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 ] [ Designated as safety issue: No ]
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 Outcome Measures:

Patients' Rating of the Overall Improvement at Week 8 [ Time Frame: Baseline and Week 8 ] [ Designated as safety issue: No ]
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. [ Time Frame: Week 8 ] [ Designated as safety issue: No ]
At the end of the trial, the patients were asked which ointment they preferred.

Enrollment:	38
Study Start Date:	November 2009
Study Completion Date:	December 2010
Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Active Comparator: refined indigo naturalis ointment 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	Drug: refined 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. Other Name: refined ointment
Active Comparator: crude indigo naturalis ointment 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	Drug: crude 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. Other Name: Crude ointment

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.

Eligibility

Ages Eligible for Study:	20 Years to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

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.

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT01022502

Locations

Taiwan
Chang Gung Memorial Hospital
Keelung, Taiwan, 204

Sponsors and Collaborators

Yin-ku Lin

Investigators

Principal Investigator:

Yin-Ku Lin, MD. PhD.

Chang Gung Memorial Hospital

More Information

No publications provided

Responsible Party:	Yin-ku Lin, Chief of Department of Traditional Chinese Medicine, Chang Gung Memorial Hospital
ClinicalTrials.gov Identifier:	NCT01022502 History of Changes
Other Study ID Numbers:	CMRPG280391
Study First Received:	November 25, 2009
Results First Received:	October 1, 2011
Last Updated:	September 14, 2012
Health Authority:	Taiwan: Institutional Review Board

Keywords provided by Chang Gung Memorial Hospital:

psoriasis, indigo naturalis

Additional relevant MeSH terms:

Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases

ClinicalTrials.gov processed this record on May 16, 2013