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

Intertrigo Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04325490
• Other study ID #: Ezerra intertrigo
• Status: Completed
• Phase: Phase 4
• Start date: October 1, 2019
• Est. completion date: September 30, 2020

Study information

• Verified date: April 2021
• Source: Mahidol University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 30, 2020
• Est. primary completion date: September 30, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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 ??? stimutex AS, aloe Barbadensis, rosa hip oil ??? allantoin, or topical hydrocortisone

4. Pregnant or breastfeeding women

5. Patients with severe intertrigo treated with high potent topical steroid or systemic corticosteroid

Related Conditions & MeSH terms

• Intertrigo

Intervention

Drug:
• Liquid powder
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.
• Hydrocortisone cream 1%
apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.

Locations

Country	Name	City	State
Thailand	Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University	Bangkoknoi	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Mahidol University	HOE pharmaceuticals Sdn. Bhd.

Country where clinical trial is conducted

Thailand, 

References & Publications (8)

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. Review. — View 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. — View Citation

Hay RJ. The management of superficial candidiasis. J Am Acad Dermatol. 1999 Jun;40(6 Pt 2):S35-42. Review. — View 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. Review. — View Citation

Kalra MG, Higgins KE, Kinney BS. Intertrigo and secondary skin infections. Am Fam Physician. 2014 Apr 1;89(7):569-73. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	2 weeks
Secondary	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.	2 weeks
Secondary	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).	2 weeks