Atopic Dermatitis Clinical Trial
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.
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.
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