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Atopic DermatitisPhase 2NCT02669888

Indigo Naturalis in Treating Atopic Dermatitis Topically

A Phase 2 study testing Indigo naturalis ointment in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. The aims of this project are: 1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically; 2. To evaluate the safety of indigo naturalis ointment in treating AD topically; 3. Read more about this study

Who is it for?
Ages 6 to 65 years
Conditions the study is for
Atopic Dermatitis
What is being tested?
Indigo naturalis ointment
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
48 participants
Where
3 sitesTaiwan
Study dates
Oct 2015to Feb 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 6 to 65 years
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • Between 6 and 65 years old, female or male.
  • Atopic dermatitis fulfilling the diagnostic criteria of Williams et al.
  • Atopic dermatitis involving <40% of BSA. (Base on the BSA result of Screening)
  • An Investigator's Global Assessment (IGA) score of 2, 3 or 4 which corresponds to mild, moderate or severe disease. (Base on the IGA result of Screening)
  • Female patients of child-bearing age with negative pregnancy test at screening.
  • Female patients of child-bearing age that agree to continue using birth control measures approved by the investigator and agree not to lactate for the duration of the study.
  • Agree to only receive stable doses of an additive-free, basic bland emollient for at least 7 days before baseline (day0)
  • Willing to comply with study protocol and agree to sign an informed consent form.

Who cannot join

  • Having a history of topical or systematical hypersensitivity to indigo naturalis or its excipient (e.g. beeswax) in ointment
  • Undergoing phototherapy (e.g. UVB, PUVA) or systemic therapy (e.g. Immunosuppressive agents) within 30 days.
  • Having used topical therapy (e.g. topical corticosteroids) for dermatitis within 7 days before the first application of the study medication.
  • Having a significant concurrent disease, such as: significant abnormalities in hematology, severe uncontrolled metabolic syndrome (e.g., hypertension, diabetes mellitus, metabolic arthritis, hyperthyroidism), psychiatric disease, cancer or AIDS.
  • Having abnormal liver or renal function (AST/ALT >3 x ULN, creatinine >2.0 mg/dl).
  • Women who are lactating, pregnant or preparing to be pregnant.

Trial locations and contacts

3 sites in 1 country.

Taiwan3 sites

  • Chang Gung Memorial Hospital at Keelung

    Kelung, Taiwan, 204

  • Chang Gung Memorial Hospital at Taipei

    Taipei, Taiwan, 105

  • Chang Gung Memorial Hospital at Linkou

    Taoyuan, Taiwan, 333

Other trials in Taiwan

About this study

Official title: Efficacy and Safety of Topical Indigo Naturalis in Treating Atopic Dermatitis: A Randomized, Double-Blind, Placebo-Controlled Trial

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. The aims of this project are:

  1. To evaluate the efficacy of indigo naturalis ointment in treating AD topically;
  2. To evaluate the safety of indigo naturalis ointment in treating AD topically;
  3. To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD;
  4. To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.
Read the detailed description

Atopic dermatitis (AD) is a chronic inflammatory skin disorder that most commonly occurs in children. AD is characterized by itchy and dry skin that affects approximately 5 to 20% of children in the world. Currently, corticosteroids are the most widely prescribed medication in treating AD; however, there are concerns regarding the side effects such as skin atrophy, telangiectasia, striae, folliculitis and adrenocortical suppression that inhibits growth in children. Many patients and families seek complementary and alternative medications such as traditional Chinese medicine (TCM). In TCM, indigo naturalis has been used to treat various infectious and inflammatory skin diseases for hundreds of years. Ancient TCM literature has recorded that indigo naturalis is also effective in treating facial eczema (AD) in infants.

The aims of this project are: (1) To evaluate the efficacy of indigo naturalis ointment in treating AD topically; (2) To evaluate the safety of indigo naturalis ointment in treating AD topically; (3) To investigate whether indigo naturalis ointment treatment is associated with a change in total IgE, cytokines, eosinophils, and CRP in patients with AD; (4) To evaluate whether indigo naturalis ointment treatment improves the quality of life in patients with AD.

Being tested
Indigo naturalis ointment, Placebo
Keywords
Indigo Naturalis, Atopic Dermatitis, TCM
Medical subject headings
Dermatitis, Atopic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Indigo naturalis ointmentDrug

    Also called Lindioil ointment

    Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.

  • PlaceboDrug

    Every 10 x 10 cm area of lesion requires 0.5 g of ointment, applied twice daily (morning and evening, separated by approximately 12±2 hours) for 6 weeks.

Study groups in NCT02669888
Study groupRoleWhat they receive
Indigo naturalis ointmentExperimental1. Form: ointment 2. Dose: each gram of ointment contains 200µg of indirubin 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Receives: Drug: Indigo naturalis ointment
PlaceboPlacebo comparator1. Form: ointment 2. Dose: vehicle 3. Dosing schedule: apply 0.5g of ointment per 10 x 10 dermatitis lesion twice daily
Receives: Drug: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6

    The Eczema Area and Severity Index (EASI) is used to measure the disease severity of erythema, infiltration/papulation, excoriation, and lichenification each on a scale of 0 to 3 (none to severe) as well as the percentage of disease area on a scale of 0 to 6 for the head ⁄ neck, upper limb, trunk and lower limb body regions. Each body region score is calculated by multiplying the disease severity score by the disease area score and by the multiplier. The scores are summed to give the total EASI score, ranging from 0 to a maximum 72.

    The mean percentage change in EASI = (EASI baseline-EASI post-treat) / EASI baseline x 100%

    Measured: 6 weeks

Secondary outcomes (8)

  1. Proportion of subjects who have achieved EASI-50, EASI-75, and EASI-90 after 6 weeks of treatment

    It is defined as at least 50%, 75%, and 90% reduction in EASI score relative to the baseline.

    Measured: 6 weeks

  2. Proportion of subjects with a change in Investigator's Global Assessment (IGA, range 0-5) from baseline to week 6.

    1. Proportion of subjects with an IGA score of 0 (clear) or 1 (almost clear) at week 6.
    2. Proportion of subjects with ≥ 2 point improvement in IGA at week 6.

    Measured: 6 weeks

  3. The mean percentage change in Total Body Surface Area involved with AD (BSA, range 0%-100%) from baseline to week 6.

    BSA is total Body Surface Area involved, ranging from 0% (none) to 100% (total body surface involved)

    Measured: 6 weeks

  4. The mean change in pruritus score (10-cm visual analogue scale) from baseline to week 6.

    Visual Analogue Scale (VAS) for pruritus severity rates from 0 (no itching) to 10 (very severe itching)

    Measured: 6 weeks

  5. Clinical-immunological correlation between the treatment outcome and the changes in the level of immunoglobin E (IgE), cytokines, eosinophil count, and C-reactive protein (CRP) in the peripheral blood from baseline to week 6.

    Measuring the correlations of treatment by EASI score and BSA, with the changes in IgE, eosinophils, cytokines (IL-1β, IL-6, TNF-α…) from baseline to week 6.

    Measured: 6 weeks

  6. The mean change in Dermatology Life Quality Index (DLQI)from baseline to week 6

    The DLQI is a self-administered 10-item questionnaire, ranges from 0 (best) to 30 (worst); the higher the score, the more quality of life is impaired.

    For subjects from age 6 to age 16, children's DLQI (CDLQI) will used.

    Measured: 6 weeks

  7. Physician's Global Assessment (PGA ) at week 6.

    0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition

    Measured: 6 weeks

  8. Subject's Global Assessment (SGA) at week 6.

    0 = Symptoms cleared or excellent improvement of 90-100%; 1 = Marked improvement of 75-89%; 2 = Moderate improvement of 50-74%; 3 = Slight improvement of 3049%; 4 = No appreciable improvement of 029%; 5 = Worsening of the condition

    Measured: 6 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted1 Feb 2016 (estimated)
  2. Study startOct 2015
  3. Primary completionJan 2017
  4. Study completionFeb 2017

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
48 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02669888
Sponsor's protocol ID
MOST 104-2325-B-182A-005
Status last verified
Feb 2017
First submitted
28 Dec 2015
Last updated
14 Feb 2017
Results posted
No
Data monitoring committee
No
Individual data sharing
No

Publications

  • Lin YK, Chang SH, Yang CY, See LC, Lee BH, Shih IH. Efficacy and safety of indigo naturalis ointment in Treating Atopic Dermatitis: A randomized clinical trial. J Ethnopharmacol. 2020 Mar 25;250:112477. doi: 10.1016/j.jep.2019.112477. Epub 2019 Dec 12.

    PubMed 31838180

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Indigo naturalis ointment in people with Atopic Dermatitis, run by Chang Gung Memorial Hospital at 3 sites in Taiwan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 8 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Feb 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 3 sites in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage change in Eczema Area Severity Index (EASI) scores from baseline to week 6 (time frame: 6 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02669888, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Feb 2017.

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