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

Primary Purpose

Intertrigo

Status
Completed
Phase
Phase 4
Locations
Thailand
Study Type
Interventional
Intervention
Liquid powder
Hydrocortisone cream 1%
Sponsored by
Mahidol University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Intertrigo focused on measuring Intertrigo, Tapioca starch, Stimutex AS, Aloe barbadensis, Rose hip oil, Allantoin

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Liquid powder

Hydrocortisone

Arm Description

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

1% hydrocortisone cream

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
Side effects were calculated by the percentage of patients developed any side effects such as dryness, scaling, atrophy, and telangiectasia at week 2.
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.
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).

Full Information

First Posted
February 2, 2020
Last Updated
April 18, 2021
Sponsor
Mahidol University
Collaborators
HOE pharmaceuticals Sdn. Bhd.
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1. Study Identification

Unique Protocol Identification Number
NCT04325490
Brief Title
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

2. Study Status

Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
September 30, 2020 (Actual)
Study Completion Date
September 30, 2020 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Mahidol University
Collaborators
HOE pharmaceuticals Sdn. Bhd.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Intertrigo
Keywords
Intertrigo, Tapioca starch, Stimutex AS, Aloe barbadensis, Rose hip oil, Allantoin

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Model Description
A double-blined, randomized study
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
the two interventions were prepared in an identical neutral package. The same investigator evaluated the skin condition at each follow-up visit. Patients were followed up at 2 weeks.
Allocation
Randomized
Enrollment
40 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Liquid powder
Arm Type
Experimental
Arm Description
Liquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin on the selected intertrigo area.
Arm Title
Hydrocortisone
Arm Type
Active Comparator
Arm Description
1% hydrocortisone cream
Intervention Type
Drug
Intervention Name(s)
Liquid powder
Intervention Description
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
Intervention Type
Drug
Intervention Name(s)
Hydrocortisone cream 1%
Intervention Description
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
Primary Outcome Measure Information:
Title
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.
Description
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.
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
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.
Description
Side effects were calculated by the percentage of patients developed any side effects such as dryness, scaling, atrophy, and telangiectasia at week 2.
Time Frame
2 weeks
Title
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.
Description
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).
Time Frame
2 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kanokvalai Kulthanan, M.D.
Organizational Affiliation
Mahidol University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University
City
Bangkoknoi
State/Province
Bangkok
ZIP/Postal Code
10700
Country
Thailand

12. IPD Sharing Statement

Citations:
PubMed Identifier
27554869
Citation
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Results Reference
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PubMed Identifier
20626853
Citation
Mistiaen P, van Halm-Walters M. Prevention and treatment of intertrigo in large skin folds of adults: a systematic review. BMC Nurs. 2010 Jul 13;9:12. doi: 10.1186/1472-6955-9-12.
Results Reference
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PubMed Identifier
30987588
Citation
Gabriel S, Hahnel E, Blume-Peytavi U, Kottner J. Prevalence and associated factors of intertrigo in aged nursing home residents: a multi-center cross-sectional prevalence study. BMC Geriatr. 2019 Apr 15;19(1):105. doi: 10.1186/s12877-019-1100-8.
Results Reference
background
PubMed Identifier
24695603
Citation
Kalra MG, Higgins KE, Kinney BS. Intertrigo and secondary skin infections. Am Fam Physician. 2014 Apr 1;89(7):569-73.
Results Reference
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PubMed Identifier
21396557
Citation
Wolf R, Oumeish OY, Parish LC. Intertriginous eruption. Clin Dermatol. 2011 Mar-Apr;29(2):173-9. doi: 10.1016/j.clindermatol.2010.09.009.
Results Reference
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PubMed Identifier
10367915
Citation
Hay RJ. The management of superficial candidiasis. J Am Acad Dermatol. 1999 Jun;40(6 Pt 2):S35-42. doi: 10.1016/s0190-9622(99)70396-8.
Results Reference
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PubMed Identifier
21747256
Citation
Black JM, Gray M, Bliss DZ, Kennedy-Evans KL, Logan S, Baharestani MM, Colwell JC, Goldberg M, Ratliff CR. MASD part 2: incontinence-associated dermatitis and intertriginous dermatitis: a consensus. J Wound Ostomy Continence Nurs. 2011 Jul-Aug;38(4):359-70; quiz 371-2. doi: 10.1097/WON.0b013e31822272d9.
Results Reference
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PubMed Identifier
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Citation
Janniger CK, Schwartz RA, Szepietowski JC, Reich A. Intertrigo and common secondary skin infections. Am Fam Physician. 2005 Sep 1;72(5):833-8.
Results Reference
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Tapioca Starch Stimutex AS, Aloe Barbadensis, Rose Hip Oil, Allantoin Comparing With Topical 1% Hydrocortisone Cream

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