Doppelblinde, prospektiv-randomisierte, intraindividuell-halbseitenvergleichende Studie zur klinischen Wirksamkeit von Verrumal® Lsg. bei aktinischen Keratosen gegen Vehikel: Investigator-initiierte “Proof-of-Concept“-Studie Doubleblind, prospective-randomised, intraindividuell-halfsite-comparing study regarding the clinical efficacy of Verrumal in the treatment of actinic keratosis vs. placebo: investigator-initiated proof-of-concept study

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2006-005034-20-DE

Enrollment

Registered

2006-11-22

Start date

2007-03-08

Completion date

Unknown

Last updated

2012-03-19

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

Conditions

Actinic keratosis is a precancerous skin growth usually caused by sun exposure. Symptoms: Rough and dry textured skin lesion, macule, patch, or growth on the skin Located on sun-exposed areas. Actinic keratosis itself is benign, but it may develop into skin cancer. Complications may be: Squamous cell carcinoma, irritation and discomfort of the skin growth MedDRA version: 8.1 Level: LLT Classification code 10000614 Term: Actinic keratosis

Interventions

Trade Name: Verrumal Lösung Pharmaceutical Form: Spot-on solution CAS Number: 69727 Other descriptive name: SALICYLIC ACID Concentration unit: % percent Concentration type: equal Concentration number:

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: written informed consent 18 years of age or older at least two clinically stated actinic keratoses of similar severity (maximum 10% deviation in size) and localisation Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range

Exclusion criteria

Exclusion criteria: indication for different therapy due to size of lesions history of invasive squamous cell carcinoma known sensitivity to any ingredients of the study medication renal insufficiency DPD deficiency other local treatments (e.g. cytostatica, Brivudin) have to be stopped at least 4 weeks prior to study start systemic therapie with cytostica or immun suppresiva and local radiation therapy

Design outcomes

Primary

Measure	Time frame
Main Objective: Global Assessment of disease under treatment with Verrumal (actinic keratosis unchanged – slightly changed, definitely changed , almost gone, gone);Secondary Objective: Area, hyperkeratosis, scales, erythema of actinic keratosis under treatment with Verrumal;Primary end point(s): Global Assessment by investigator (actinic keratoses unchanged – slightly changed, definitely changed, almost gone, gone)	—

Measure

Time frame

Main Objective: Global Assessment of disease under treatment with Verrumal (actinic keratosis unchanged – slightly changed, definitely changed , almost gone, gone);Secondary Objective: Area, hyperkeratosis, scales, erythema of actinic keratosis under treatment with Verrumal;Primary end point(s): Global Assessment by investigator (actinic keratoses unchanged – slightly changed, definitely changed, almost gone, gone)

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Countries

Germany

Outcome results

None listed

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