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bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients


Phase 2
18 Years
N/A
Open (Enrolling)
Both
Cutaneous Warts

Thank you

Trial Information

bLAC - A Phase II Double-Blind, Placebo Controlled, Clinical Proof of Concept Trial of the Efficacy of 8 Weeks Treatment of Cutaneous Warts With bLAC in Immune Suppressed, Kidney Transplanted Patients


Inclusion Criteria:



- Cutaneous warts on ingers and/or palms and/or toes and/or soles of feet

- Common warts and mosaic warts, diagnosed by an experienced dermatologist

- Solitary wart lesions or 2 or more lesions per patient

- Lesions present for more than 6 months

- Men or women, aged 18 or above

- History of kidney transplantation and immune suppressive therapy after transplant

- Concomitant immune suppressive therapy stable for 6 months prior to randomization

- Agreement from patient to allow photographs to be taken and used as part of trial
data documentation (2 centres)

- Women of childbearing potential must have negative pregnancy test at screening and
must use adequate contraception

- Ability to comply with requirements of trial

- Written informed consent

Exclusion Criteria:

- Verruca plana lesions

- Suspected allergy to milk verified by serum analysis of IgE towards cow milk

- Breastfeeding

- Any local medication for any purpose other than wart treatment in target area during
4 weeks prior to randomization and during treatment period

- Concomitant treatment with other wart therapies two weeks prior to randomization and
during trial period

- Intolerance towards bovine alpha-lactalbumin, oleic acid or any excipient in the
formulation

- Known HIV infection or any current uncontrolled infection

- Any chronic or acute skin condition susceptible of interfering with evaluation of
drug effect in this trial

- Participation in any investigational trial or use of any investigational drug within
30 days prior to inclusion in this trial

- Any health problems which according to Investigator's clinical judgment will make the
patient unsuitable for inclusion in the trial

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment

Outcome Measure:

Reduction in the area of wart lesions located on fingers and/or palms and/or toes and/or soles of the feet, measured by an objective method by drawing of individual lesions

Outcome Time Frame:

Prospective

Safety Issue:

No

Principal Investigator

Claus Zachariae, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Gentofte Amtssygehus

Authority:

Denmark: Danish Medicines Agency

Study ID:

CL-1205

NCT ID:

NCT00644579

Start Date:

March 2008

Completion Date:

February 2009

Related Keywords:

  • Cutaneous Warts
  • wart
  • cutaneous
  • transplant
  • Cutaneous warts in immune suppressed, kidney transplant patients
  • Warts

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