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
Verified date | April 2021 |
Source | Mahidol University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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
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 |
Country | Name | City | State |
---|---|---|---|
Thailand | Department of Dermatology, Faculty of Medicine Siriraj Hospital, Mahidol University | Bangkoknoi | Bangkok |
Lead Sponsor | Collaborator |
---|---|
Mahidol University | HOE pharmaceuticals Sdn. Bhd. |
Thailand,
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
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 |
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