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

April 18, 2021 updated by: Mahidol University

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

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Thailand
    • Bangkok
      • Bangkoknoi, Bangkok, Thailand, 10700
        • Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

16 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Liquid powder
Liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin on the selected intertrigo area.
Drug: Liquid powder
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
Active Comparator: Hydrocortisone
1% hydrocortisone cream
Drug: Hydrocortisone cream 1%
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks
Efficacy was evaluated by the number of patients with improvement in erythema scores on intertrigo lesion after treatment which were assessed by the patients and the same investigator. Erythema scores were recorded using a 4-point scale (0 = none, 1 = mild, 2 = moderate, 3 = severe) on intertrigo lesion at baseline and week 2.
2 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 2 weeks
Side effects were calculated by the percentage of patients developed any side effects such as dryness, scaling, atrophy, and telangiectasia at week 2.
2 weeks
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.
Time Frame: 2 weeks
Satisfaction was measured on intertrigo lesion at the end of study visit by patients using visual analog scales (VAS). The minimum score is 0 (no satisfied) and the maximum score is 10 (most satisfied).
2 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mahidol University

Collaborators

HOE pharmaceuticals Sdn. Bhd.

Investigators

  • Principal Investigator: Kanokvalai Kulthanan, M.D., Mahidol University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 1, 2019

Primary Completion (Actual)

September 30, 2020

Study Completion (Actual)

September 30, 2020

Study Registration Dates

First Submitted

February 2, 2020

First Submitted That Met QC Criteria

March 26, 2020

First Posted (Actual)

March 27, 2020

Study Record Updates

Last Update Posted (Actual)

April 20, 2021

Last Update Submitted That Met QC Criteria

April 18, 2021

Last Verified

April 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Ezerra intertrigo

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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