## Protocol Section
### Identification Module
**NCT ID:** NCT00644579

**Brief Title:** bLAC - Treatment of Cutaneous Warts in Immune Suppressed, Kidney Transplanted Patients

**Official Title:** 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

#### Organization Study ID Info
**ID:** CL-1205
#### Organization
**Class:** INDUSTRY
**Full Name:** NatImmune A/S
#### Secondary ID Infos
**ID:** EudraCT number: 2007-006738-33
### Status Module
#### Completion Date
**Date:** 2009-02

**Type:** ESTIMATED

#### Expanded Access Info
**Last Known Status:** RECRUITING
#### Last Update Post Date
**Date:** 2008-03-27

**Type:** ESTIMATED

**Last Update Submit Date:** 2008-03-26

**Overall Status:** UNKNOWN

#### Primary Completion Date
**Date:** 2008-12

**Type:** ESTIMATED

#### Start Date
**Date:** 2008-03

**Status Verified Date:** 2008-03

#### Study First Post Date
**Date:** 2008-03-27
**Type:** ESTIMATED
**Study First Submit Date:** 2008-03-25
**Study First Submit QC Date:** 2008-03-26
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** INDUSTRY

**Name:** NatImmune A/S

#### Responsible Party

**Old Name Title:** NatImmune A/S

**Old Organization:** NatImmune

### Oversight Module

**Oversight Has DMC:** False

### Description Module

**Brief Summary:** As many as 85 % of renal transplant patients may suffer from viral warts with a high degree of treatment resistance. Promising results of hLAC (human lactalbumin complex with lipid) point to a beneficial effect without noticeable side effects of bLAC (bovine lactalbumin complex with lipid). The aim of first clinical trial with bLAC is to show proof of concept in treatment of cutaneous wart lesions on hands and/or feet after local administration of bLAC in two dose groups to immune suppressed, kidney transplanted patients.

### Conditions Module

**Conditions:**

- Cutaneous Warts

**Keywords:**

- wart

- cutaneous

- transplant

- Cutaneous warts in immune suppressed, kidney transplant patients

### Design Module

#### Design Info

**Allocation:** RANDOMIZED

**Intervention Model:** PARALLEL

##### Masking Info

**Masking:** QUADRUPLE

**Who Masked:**

- PARTICIPANT

- CARE_PROVIDER

- INVESTIGATOR

- OUTCOMES_ASSESSOR

**Primary Purpose:** TREATMENT

#### Enrollment Info

**Count:** 120

**Type:** ESTIMATED

**Phases:**

- PHASE2

**Study Type:** INTERVENTIONAL

### Arms Interventions Module

#### Arm Group 1

**Description:** bLAC high dose

**Intervention Names:**

- Drug: bLAC

**Label:** 1

**Type:** ACTIVE_COMPARATOR

#### Arm Group 2

**Description:** bLAC low dose

**Intervention Names:**

- Drug: bLAC

**Label:** 2

**Type:** ACTIVE_COMPARATOR

#### Arm Group 3

**Intervention Names:**

- Drug: Placebo

**Label:** 3

**Type:** PLACEBO_COMPARATOR

### Interventions

#### Intervention 1

**Arm Group Labels:**

- 1

- 2

**Description:** bLAC high and low dose and placebo

**Name:** bLAC

**Type:** DRUG

#### Intervention 2

**Arm Group Labels:**

- 3

**Description:** Placebo

**Name:** Placebo

**Type:** DRUG

### Outcomes Module

#### Primary Outcomes

**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

**Time Frame:** Prospective

#### Secondary Outcomes

**Measure:** Clearance of index wart lesions. Time to clearance of warts. Recurrence rate of previously cleared wart lesions. Occurrence of new warts.overall changes of index warts lesions. Safety and tolerability.

**Time Frame:** Prospective

### Eligibility Module

**Eligibility Criteria:** 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

**Minimum Age:** 18 Years

**Sex:** ALL

**Standard Ages:**

- ADULT

- OLDER_ADULT

### Contacts Locations Module

#### Central Contacts

**Contact 1:**

**Email:** clza@geh.regionh.dk

**Name:** Claus Zachariae, MD, Chief Physician

**Phone:** +4539773203

**Role:** CONTACT

#### Locations

**Location 1:**

**City:** Aalborg

**Contacts:**

***Contact 1:***

- **Name:** Henrik Sølvsten, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Dermatology Clinic, Vesterbro

**Status:** RECRUITING

**Zip:** DK-9000

**Location 2:**

**City:** Aarhus C

**Contacts:**

***Contact 1:***

- **Name:** Mette S Deleuran, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Marselisborg University Hospital

**Status:** RECRUITING

**Zip:** DK-8000

**Location 3:**

**City:** Copenhagen NV

**Contacts:**

***Contact 1:***

- **Name:** Merete Hædersdal, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Bispebjerg University Hospital

**Status:** RECRUITING

**Zip:** DK-2400

**Location 4:**

**City:** Hellerup

**Contacts:**

***Contact 1:***

- **Name:** Claus Zachariae, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Gentoftte Amtssygehus

**Status:** RECRUITING

**Zip:** DK-2900

**Location 5:**

**City:** Odense

**Contacts:**

***Contact 1:***

- **Name:** Henrik Lorentzen, MD

- **Role:** PRINCIPAL_INVESTIGATOR

**Country:** Denmark

**Facility:** Odense University Hospital

**Status:** RECRUITING

**Zip:** DK-5000

#### Overall Officials

**Official 1:**

**Affiliation:** Gentofte Amtssygehus

**Name:** Claus Zachariae, MD

**Role:** PRINCIPAL_INVESTIGATOR

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000030361

- Term: Papillomavirus Infections

- ID: D000004266

- Term: DNA Virus Infections

- ID: D000014777

- Term: Virus Diseases

- ID: D000007239

- Term: Infections

- ID: D000017193

- Term: Skin Diseases, Viral

- ID: D000014412

- Term: Tumor Virus Infections

- ID: D000012874

- Term: Skin Diseases, Infectious

- ID: D000012871

- Term: Skin Diseases

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC17

- Name: Skin and Connective Tissue Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: BXS

- Name: Urinary Tract, Sexual Organs, and Pregnancy Conditions

### Condition Browse Module - Browse Leaves

- ID: M17603

- Name: Warts

- Relevance: HIGH

- As Found: Warts

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M23687

- Name: Papillomavirus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M17522

- Name: Virus Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M7442

- Name: DNA Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15674

- Name: Skin Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M19501

- Name: Skin Diseases, Viral

- Relevance: LOW

- As Found: Unknown

- ID: M17162

- Name: Tumor Virus Infections

- Relevance: LOW

- As Found: Unknown

- ID: M15677

- Name: Skin Diseases, Infectious

- Relevance: LOW

- As Found: Unknown

### Condition Browse Module - Meshes

- ID: D000014860

- Term: Warts

### Misc Info Module

- Version Holder: 2024-05-24
