Trial | NCT04325490  Report issue

Title

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

  • Phase

    Phase 4

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    40
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
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.
Study Started
Oct 01
2019
Primary Completion
Sep 30
2020
Study Completion
Sep 30
2020
Last Update
Apr 20
2021

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.

Liquid powder Experimental

Liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin on the selected intertrigo area.

Hydrocortisone Active Comparator

1% hydrocortisone cream

Criteria 

Inclusion Criteria:

Patients who had age more than 18 years
One intertrigo lesion at inframammary fold, inguinal region, interdigital, axilla or abdominal region with mild to moderate which only has erythema no epidermal loss
Being diagnosed intertrigo by dermatologist. Patients will be clinical and investigational with KOH preparation and Wood's lamp diagnosed with intertrigo by dermatologist.

Exclusion Criteria:

Patients receive topical steroids, topical anti-fungal drugs within 2 weeks prior the study
Patients with skin conditions including fungal/bacterial infection, Hailey-Hailey disease, pemphigus, granuloma, psoriasis, acanthosis, or Darier disease on intertriginous areas within 2 weeks prior to the study
Patients with an allergic to tapioca starch และ stimutex AS, aloe Barbadensis, rosa hip oil และ allantoin, or topical hydrocortisone
Pregnant or breastfeeding women
Patients with severe intertrigo treated with high potent topical steroid or systemic corticosteroid
No Results Posted