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Randomised controlled trial of the treatment of warts in general practice.

Randomised controlled trial of the treatment of warts in general practice.

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
NL-OMON
Registry ID
NL-OMON26788
Enrollment
250
Registered
2005-09-22
Start date
2006-03-01
Completion date
Unknown
Last updated
2024-02-28

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

Conditions

Common (not genital) warts

Interventions

Treatment arms For the treatment with cryotherapy we chose for a high-intensity regimen: a 2-weekly consultation till the wart has disappeared (until max. 13 weeks), 3 applications of the same wart pe

Sponsors

None listed

Eligibility

Inclusion criteria

Inclusion criteria: All patients from the age of 4 onward, who present themselves to their practice with one or more new warts of the type vulgaris on hands or feet will be included? New warts are warts who are presented for the first time in the general practice by patients who have had no general practice (or dermatological) treatment for warts in the past year. For all patients duration of presence of the warts and the previous treatment(s) will be registered.

Exclusion criteria

Exclusion criteria: Exclusion criteria are: immuno-incompetent patients and mosaic warts larger than 1 cm in diameter.

Design outcomes

Primary

MeasureTime frame
The primary outcome is defined as ‘cure', which means that the wart(s) have totally disappeared (normal skin) at 13 weeks.

Secondary

MeasureTime frame
1. The number of warts that still exists at follow-up, irrespective of the extent of regression (because for a separate wart regression can not be validly assessed.); 2. The subjective hindrance caused by the warts as scored by the patient on a numerical rating scale (0-10); 3. The subjective hindrance caused by the treatment as scored by the patient on a seven point scale (during the treatment period this will be scored weekly in a booklet); 4. Pain and other adverse effects of the treatments (pain, new warts, scars, irritation of the skin, dermatitis discomfort, invalidation, time); 5. Subjective judgement of the effect of the treatment by the patient at follow-up subjective judgement of the effect of the treatment by the research nurse at follow-up; 6. Referral to a dermatological department , assessed at 26 weeks After three months of the intervention period, patients for whom the warts have not disappeared are free to Switch therapy. In the follow-up period we will carefully register to which therapies patients have switched and also if, and after how long this therapy leads to total disappearance of the warts; 7. The consumption of co-interventions during the intervention period and thereafter will also be used as secondary endpoints.

Contacts

Public ContactJ.A.H. Eekhof

Leiden University Medical Center (LUMC), P.O. Box 2088

j.a.h.eekhof@lumc.nl+31 (0)71 5275318

Outcome results

None listed

Source: NL-OMON (via WHO ICTRP)