Phase 2 RCT mushroom extract cream for atopic dermatitis

A Phase 2a, blinded, split site, proof-of-concept study comparing the safety and efficacy of a topical cream containing Lignosus rhinocerus extract (TM02®) to standard of care treatment in adolescent and adult subjects with mild to moderate atopic dermatitis

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2025002009

Enrollment

Unknown

Registered

2025-10-22

Start date

2022-03-01

Completion date

Unknown

Last updated

2025-11-17

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

Conditions

mild to moderate atopic dermatitis

Interventions

test:topical cream containing Lignosus rhinocerus extract (TM02®)

standard care:topical hydrocortisone 1% cream

Eligibility

Sex/Gender

All

Age

12 Years to 80 Years

Inclusion criteria

Inclusion criteria: i.Male or female aged 12 years and above at baseline (day 1) ii.Clinical diagnosis of AD according to the Hanifin and Rajka criteria iii.Mild-to-moderate disease severity based on EASI score at baseline iv.Stable AD for at least one month v. Presence of 2 comparable study sites, eg: both cubital fossa or popliteal fossa affected by AD

Exclusion criteria

Exclusion criteria: i.Any clinically significant medical disorder, condition, or disease or clinically significant ii.physical examination finding at screening that may interfere with study objectives or safety iii.Unstable AD iv.Hypersensitivity to components of TM02® cream or vehicle v.Active systemic or localised infection vi.Use of systemic therapies within 4 weeks or biologic therapies within 12 weeks or 5 half-lives vii.(if known), whichever longer, for AD viii.Phototherapy treatment, laser treatment or extended sun exposure within 4 weeks ix.Oral, topical or parenteral traditional Chinese medicine within 4 weeks x.Topical corticosteroids, topical calcineurin inhibitors or topical phosphodiesterase-4 (PDE-4) xi.inhibitors to test sites within 7 days xii.Use of antihistamines within 14 days xiii.Pregnancy or lactation

Design outcomes

Primary

Measure	Time frame
Change from baseline in Atopic Dermatitis Severity Index (ADSI) and objective SCORing Atopic Dermatitis (SCORAD) scores at day 28;	—

Secondary

Measure	Time frame
Change from baseline to days 28 and 42 in worst pruritus numerical rating scale (NRS);Change from baseline to days 28 and 42 in Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CLDQI) where applicable;Proportion of subjects achieving DLQI or CDLQI 0/1 at days 28 and 42 ;Change from baseline to days 28 and 42 in skin hydration and transepidermal water loss (TEWL) in target lesions based on Corneometer® and Tewameter® readings respectively ;Change from baseline in ADSI and objective SCORAD scores at day 42 ;Change from baseline in Eczema Area and Severity Index (EASI) scores at days 28 and 42;	—

Measure

Time frame

Change from baseline to days 28 and 42 in worst pruritus numerical rating scale (NRS);Change from baseline to days 28 and 42 in Dermatology Life Quality Index (DLQI) or Children's Dermatology Life Quality Index (CLDQI) where applicable;Proportion of subjects achieving DLQI or CDLQI 0/1 at days 28 and 42 ;Change from baseline to days 28 and 42 in skin hydration and transepidermal water loss (TEWL) in target lesions based on Corneometer® and Tewameter® readings respectively ;Change from baseline in ADSI and objective SCORAD scores at day 42 ;Change from baseline in Eczema Area and Severity Index (EASI) scores at days 28 and 42;

—

Countries

Malaysia

Contacts

Public ContactKwan ZhenLi

Universiti Malaya

zhenli@um.edu.my+6017711 2008

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026