| Methods |
Randomised parallel‐group open‐label study |
| Participants |
60 participants with hand eczema
Inclusion criteria
18 years of age or older Mild to moderate hand dermatitis, according to the Investigator Global Assessment (score 2 to 3) Generally healthy, as determined by brief medical history Capable of understanding and signing the consent form
Exclusion criteria
Clinically relevant allergic or irritant contact dermatitis and inability to avoid exposure Severe dermatitis according to the Investigator Global Assessment (score 4) Severe vesiculation or bullae History of psoriasis, contact urticaria, and/or pustular disease Therapy with potent topical corticosteroids within 1 month before enrolment Systemic treatment with oral retinoids, corticosteroids, or PUVA within the 8‐week period before the beginning of the study History or current evidence of a chronic or infectious skin disease Pregnant or lactating, or women not using highly effective contraception Current participation in any other interventional clinical trial Received treatment with any non‐marketed drug substance (i.e. an agent that has not yet been made available for clinical use) within 4 weeks before randomisation Participant known or, in the opinion of the investigator, unlikely to comply with the Clinical Study Protocol (e.g. alcoholism, drug dependency, psychotic state)
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| Interventions |
Interventions
• Herbavate applied on affected area 3 times a day for 4 weeks
• Betamethasone + Gentamycin applied on affected area 3 times a day for 4 weeks |
| Outcomes |
Primary outcome of the trial
Secondary outcomes of the trial
Global assessment by patients (PaGA): at baseline and at the end of 2 and 4 weeks of treatment Number of adverse events during 4 weeks of treatment Number of participants with adverse events during 4 weeks of treatment Adverse events reported during the study at baseline and at the end of 2 and 4 weeks of treatment Total lesion symptom score (TLSS) at week 0, week 2, and week 4
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| Notes |
Sponsor: Troikaa Pharmaceuticals Limited
Study author was contacted on 20 February; however email was not‐working: medicalservices@troikaapharma.com. Contact through LinkedIn revealed that study results have not been published and provided no further details |
