Comparison of Refined and Crude Indigo Naturalis Ointment in Treating Psoriasis

Yin-ku Lin

Status and phase: Completed; Phase 2

Conditions: Psoriasis Vulgaris

Treatments: Drug: crude indigo naturalis ointment; Drug: refined indigo naturalis ointment

Study type: Interventional

Funder types: Other

Identifiers

NCT01022502

CMRPG280391

Details and patient eligibility

About

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

Full 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.

Enrollment: 38 patients

Sex: All

Ages: 20 to 65 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Single Group Assignment

Masking: Single Blind

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38 participants in 2 patient groups

refined indigo naturalis ointment

Active Comparator group

Description:

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

Treatment:

Drug: refined indigo naturalis ointment

crude indigo naturalis ointment

Active Comparator group

Description:

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

Treatment:

Drug: crude indigo naturalis ointment