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IntertrigoPhase 4NCT04325490

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

A Phase 4 study testing Liquid powder and Hydrocortisone cream 1% in people with Intertrigo, run by Mahidol University at 1 site in Thailand.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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 Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Intertrigo
What is being tested?
Liquid powder and Hydrocortisone cream 1%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
40 participants
Where
1 siteThailand
Study dates
1 Oct 2019to 30 Sep 2020
Phase
Phase 4
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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

Trial locations and contacts

1 site in 1 country.

Thailand1 site

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

    Bangkoknoi, Bangkok, 10700

Other trials in Thailand

About this study

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

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

Read the 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.

Conditions
Intertrigo
Being tested
Liquid powder, Hydrocortisone cream 1%
Keywords
Intertrigo, Tapioca starch, Stimutex AS, Aloe barbadensis, Rose hip oil, Allantoin
Medical subject headings
Intertrigo

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Liquid powderDrug

    apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.

  • Hydrocortisone cream 1%Drug

    apply the study drug 1 fingertip unit to cover intertrigo lesion twice a day for two weeks.

Study groups in NCT04325490
Study groupRoleWhat they receive
Liquid powderExperimentalLiquid powder containing tapioca starch stimutex AS, aloe barbadensis, rose hip oil and allantoin on the selected intertrigo area.
Receives: Drug: Liquid powder
HydrocortisoneActive comparator1% hydrocortisone cream
Receives: Drug: Hydrocortisone cream 1%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: 2 weeks

Secondary outcomes (2)

  1. 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.

    Measured: 2 weeks

  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).

    Measured: 2 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Mar 2020
  2. Study start1 Oct 2019
  3. Primary completion30 Sep 2020
  4. Study completion30 Sep 2020

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
A double-blined, randomized study
Masking
Triple blind
Who is masked
Participant, Investigator, Outcomes assessor
Enrolment
40 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04325490
Sponsor's protocol ID
Ezerra intertrigo
Status last verified
Apr 2021
First submitted
2 Feb 2020
Last updated
20 Apr 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • 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.

    PubMed 27554869

  • 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.

    PubMed 20626853

  • 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.

    PubMed 30987588

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

    PubMed 24695603

  • 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.

    PubMed 21396557

  • 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.

    PubMed 10367915

  • 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.

    PubMed 21747256

  • Janniger CK, Schwartz RA, Szepietowski JC, Reich A. Intertrigo and common secondary skin infections. Am Fam Physician. 2005 Sep 1;72(5):833-8.

    PubMed 16156342

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Liquid powder and Hydrocortisone cream 1% in people with Intertrigo, run by Mahidol University at 1 site in Thailand.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 20 Apr 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Thailand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome 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. (time frame: 2 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04325490, which also lists 8 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Apr 2021.

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