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Comparative study of a cream containing acetyl hexapeptide-49 plus herbal extracts and 1% hydrocortisone cream in the treatment of atopic dermatitis: A Randomized split-body trial

Comparative study of a cream containing acetyl hexapeptide-49 plus herbal extracts and 1% hydrocortisone cream in the treatment of atopic dermatitis: A Randomized split-body trial

Status
Recruiting
Phases
Phase 2
Study type
Interventional
Source
TCTR
Registry ID
TCTR20260322003
Enrollment
24
Registered
2026-03-22
Start date
2026-03-06
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Atopic dermatitis with mild to moderate severity Atopic dermatitis, Herbal moisturizer, Herbal cream, 1% Hydrocortisone, Skin barrier, Skin hydration

Interventions

A cream containing acetyl hexapeptide-49 plus herbal extracts will be applied on active rash of atopic dermatitis on one side of the body, as determined by randomized allocation of volunteers. The tre
Experimental Drug,Experimental Drug
A cream containing acetyl hexapeptide-49 plus herbal extracts,Hydrocortisone cream and cream base

Sponsors

Department of Dermatology, Faculty of Medicine, Srinakharinwirot University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
2 Years to 18 Years

Inclusion criteria

Inclusion criteria: 1. Age 2-18 years old, 2.Diagnosed with atopic dermatitis according to the UK Working Party diagnostic criteria, 3. Disease severity classified as mild to moderate, based on SCORAD score 0-50, 4. Presence of symmetrical lesions on both sides of the body, assessed by percentage of Body Surface Area (BSA), 5. Participants must be able to attend all scheduled follow-up visits during the study period, 6. Participants and their legal guardians must voluntarily agree to participate and sign the informed consent form prior to enrollment

Exclusion criteria

Exclusion criteria: 1. Use of topical anti-inflammatory medications within 2 weeks prior to enrollment, including topical corticosteroids, topical calcineurin inhibitors (tacrolimus, pimecrolimus), topical phosphodiesterase-4 (PDE-4) inhibitors, 2. Use of systemic anti-inflammatory or immunomodulatory treatments within 4 weeks prior to enrollment, including systemic corticosteroids, systemic immunomodulators (cyclosporine, azathioprine, methotrexate, mycophenolate mofetil), biologic agents (dupilumab), phototherapy, 3. Presence of allergic contact dermatitis, skin infection, or open wounds at the intended treatment site at baseline, 4. History of hypersensitivity or allergy to topical corticosteroids or to products containing plant-derived extracts or mineral components

Design outcomes

Primary

MeasureTime frame
Improvement of the disease Baseline, week 2, 4, 6, 8, and 12 after treatment modified SCORAD, assessed by physician

Secondary

MeasureTime frame
Level of skin hydration Baseline, week 2, and week 4 Corneometer CM825,Rate of transepidermal water loss Baseline, week 2, and week 4 TEWA meter,Patient satisfaction of the treatment Week 4 Visual analog scale (VAS),Median time to disease relapse Week 6, 8, and 12 modified SCORAD, assessed by physician

Countries

Thailand

Contacts

Public ContactMontri Udompataikul

Department of Dermatology, Faculty of Medicine, Srinakharinwirot university

umontree@gmail.com0816148432

Outcome results

None listed

Source: TCTR (via WHO ICTRP) · Data processed: Aug 10, 2026