Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

NCT01022502 | Completed Phase 2 Results DMC

• 1 other identifier: CMRPG280391
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Psoriasis Vulgaris

Keywords

psoriasis, indigo naturalis

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline and Week 8

Secondary Outcomes (2)

• Patients' Rating of the Overall Improvement at Week 8

  Baseline and Week 8

• Patients Preferred Ointment Type.

  Week 8

Study Arms (2)

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

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

Drug: crude indigo naturalis ointment

Interventions

refined indigo naturalis ointment DRUG

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.

Also known as: refined ointment

refined indigo naturalis ointment

crude indigo naturalis ointment DRUG

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.

Also known as: Crude ointment

crude indigo naturalis ointment

Eligibility Criteria

• Age: 20 Years - 65 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Yin-ku Lin: lead

Study Sites (1)

Chang Gung Memorial Hospital

Keelung, 204, Taiwan

Location

MeSH Terms

Conditions

Psoriasis

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Yin-Ku Lin, MD. PhD.
• Organization: Chang Gung Memorial Hospital

lin1266@adm.cgmh.org.tw

886-2-24313131

Study Officials

• Yin-Ku Lin, MD. PhD.

  Chang Gung Memorial Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Chief of Department of Traditional Chinese Medicine

Study Record Dates

• First Submitted: November 25, 2009
• First Posted: December 1, 2009
• Study Start: November 1, 2009
• Primary Completion: December 1, 2010
• Study Completion: December 1, 2010
• Last Updated: October 16, 2012
• Results First Posted: October 16, 2012

Record last verified: 2012-09

Locations

TW (1)