NCT04325490

Tapioca Starch Stimutex AS, Aloe Barbadensis, Rose Hip Oil, Allantoin Comparing With Topical 1% Hydrocortisone Cream

A Randomized Controlled Trial of Efficiency and Safety of Liquid Powder Containing Tapioca Starch Stimutex AS, Aloe Barbadensis, Rose Hip Oil and Allantoin Comparing With Topical 1% Hydrocortisone Cream for Treatment of Intertrigo

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Mahidol University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

A randomized controlled trial of efficiency and safety of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin comparing with topical 1% hydrocortisone cream for the treatment of intertrigo

Detailed description

Intertrigo is an inflammatory dermatosis involving body folds that develops through friction of skin to skin and is influenced by moist conditions. The prevalence of intertrigo was reported to be 2.5% for adults with an average age of 41.5 years. Prevalence of intertrigo in the large skin folds varies from 6% in hospital patients to 17% in nursing home clients and 20% in home care patients. The inframammary fold was most often affected (9.9%), followed by the inguinal region (9.4%), axilla (0.5%) and abdominal region (0.5%). Intertrigo may be mild and asymptomatic, but also may lead to intense erythema and desquamation. The affected skin may have a foul odor and may be macerated and ulcerated with copious or purulent discharge. The conventional therapy for simple intertrigo is minimizing moisture and friction. Some suggest the use of absorptive powders, such as talc and cornstarch, or barrier creams. These topical treatments such as topical steroid, however, have little or no proven benefit and may cause irritation or facilitate yeast colonization. This study aims to evaluate the efficacy and safety of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin comparing with topical 1% hydrocortisone cream of mild to moderate intertrigo patients.

Conditions

• Intertrigo

Interventions

Type	Name	Description
DRUG	Liquid powder	apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
DRUG	Hydrocortisone cream 1%	apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.

Timeline

• Start date: 2019-10-01
• Primary completion: 2020-09-30
• Completion: 2020-09-30
• First posted: 2020-03-27
• Last updated: 2021-04-20

Locations

1 site across 1 country: Thailand