Clinical trial NCT04325490: Tapioca Starch Stimutex AS, Aloe Barbadensis, Rose Hip Oil, Allantoin Comparing With Topical 1% Hydrocortisone Cream
Official title: 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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Intertrigo
Keywords: Intertrigo
Tapioca starch
Stimutex AS
Aloe barbadensis
Rose hip oil
Allantoin
Lead sponsor: Mahidol University
Sponsor class: OTHER
Collaborators: name: HOE pharmaceuticals Sdn. Bhd.
First posted: 2020-03-27
Enrollment: 40
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A double-blined, randomized study
Primary purpose: TREATMENT

Brief 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.

Eligibility criteria: Inclusion Criteria:

1. Patients who had age more than 18 years
2. One intertrigo lesion at inframammary fold, inguinal region, interdigital, axilla or abdominal region with mild to moderate which only has erythema no epidermal loss
3. 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:

1. Patients receive topical steroids, topical anti-fungal drugs within 2 weeks prior the study
2. 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
3. Patients with an allergic to tapioca starch และ stimutex AS, aloe Barbadensis, rosa hip oil และ allantoin, or topical hydrocortisone
4. Pregnant or breastfeeding women
5. Patients with severe intertrigo treated with high potent topical steroid or systemic corticosteroid

Primary outcomes:
measure: Efficacy of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin, compared to topical 1% hydrocortisone cream for the treatment of intertrigo.
timeFrame: 2 weeks
Secondary outcomes:
measure: Side effects of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin, compared to topical 1% hydrocortisone cream for the treatment of intertrigo.
timeFrame: 2 weeks
measure: Patients' satisfction of liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin, compared to topical 1% hydrocortisone cream for the treatment of intertrigo.
timeFrame: 2 weeks
Other outcomes:
Locations:
city: Bangkoknoi
country: Thailand
facility: Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
state: Bangkok
Study officials:
affiliation: Mahidol University
name: Kanokvalai Kulthanan, M.D.
role: PRINCIPAL_INVESTIGATOR
References:
citation: Ndiaye M, Taleb M, Diatta BA, Diop A, Diallo M, Diadie S, Seck NB, Diallo S, Ndiaye MT, Niang SO, Ly F, Kane A, Dieng MT. [Etiology of intertrigo in adults: A prospective study of 103 cases]. J Mycol Med. 2017 Mar;27(1):28-32. doi: 10.1016/j.mycmed.2016.06.001. Epub 2016 Aug 21. French.
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