The Efficacy of Intra-lesional Bleomycin Versus Intra-lesional Purified Protein Derivative in Treatment of Palmoplantar Warts

NCT03477448 | Unknown Phase 4

• 1 other identifier: Bleomycin Vs PPD
• Study Type: interventional
• Target: 40
• Locations: 0 countries
• Sites: N/A

Brief Summary

• Warts are common viral infections on the skin and are prevalent worldwide. Warts are caused by the human Papilloma virus (HPV), which has more than 100 strains; some of them are known to be premalignant. Although warts can appear at any age, they are more common in children and adolescents. The prognosis of warts cannot be predicted. In some patients they may spontaneously disappear, whereas others show persistence and progression with spreading to other body sites, leading to physical and emotional distress to the patients.
• Factors that increase the risk include use of public showers, working with meat, eczema, and a low immune system . The virus is believed to enter the body through skin that has been damaged slightly . A number of types exist including: common warts, plantar warts, filiform warts, and genital warts . Genital warts are often sexually transmitted.

Conditions

Warts

Outcome Measures

Primary Outcomes (1)

• The cure rate of patients

  the clinical disappearance of the warts

  One year

Study Arms (2)

PPD group

ACTIVE COMPARATOR

This group will include 20 patients who will be treated with IL injection of PPD at a dose of 10 IU (0.1 ml) supplied an insulin syringe in the largest wart. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions

Drug: Purified Protein Derivative

Bleomycin group

ACTIVE COMPARATOR

This group will include 20 patients who will be treated with IL injection of bleomycin. Injections will be repeated for all patients into the same lesion (largest wart) every 2 weeks for three treatment sessions, if needed.

Drug: Bleomycin

Interventions

Bleomycin DRUG

an antibiotic derived from Streptomyces verticillus, has an antitumor, antibacterial, and antiviral activity that may be related to its ability to bind with DNA, causing bleomycin strand scission and elimination of pyrimidine and purine bases. The bleomycin hydrolase enzyme, which is known to inactivate bleomycin, is normally found in all body tissues but is present in very small amounts in skin . * Intra-lesional bleomycin injection (IBI) has been used for the treatment of warts.

Bleomycin group

Purified Protein Derivative DRUG

is an extract of Mycobacterium tuberculosis and is used for testing exposure to tuberculin protein, either from a previous vaccination or from the environment. It contains live, attenuated Mycobacterium bovis. * Using this protein derivative for immunotherapy of warts is important for two major aspects. First, because the obligatory immunization program in many developing countries - with high prevalence of wart in many of them - includes BCG vaccination. PPD has a high prevalence of immunity in the general population. Second, although immunotherapy is generally an inexpensive method of treatment in wart patients, PPD, among conventionally used antigens, is the cheapest

PPD group

Eligibility Criteria

• Age: 15 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• Patients with positive tuberculin test or with past history of PPD vaccination will include.
• Patient with normal CBC , liver function and renal function

You may not qualify if:

• Patients with immunosuppression, pregnancy, or lactation, with negative tuberculin test or with past history of tuberculosis, peripheral vascular disease, any abnormality in liver or renal function and those who received any wart treatment 1 month before the start of the study will exclude.

Sponsors & Collaborators

• Assiut University: lead

Related Publications (2)

• Lynch MD, Cliffe J, Morris-Jones R. Management of cutaneous viral warts. BMJ. 2014 May 27;348:g3339. doi: 10.1136/bmj.g3339. No abstract available.

  PMID: 24865780 BACKGROUND

• Yamamoto T. Bleomycin and the skin. Br J Dermatol. 2006 Nov;155(5):869-75. doi: 10.1111/j.1365-2133.2006.07474.x.

  PMID: 17034512 BACKGROUND

MeSH Terms

Conditions

Warts

Interventions

Bleomycin; Tuberculin

Condition Hierarchy (Ancestors)

Papillomavirus Infections; DNA Virus Infections; Virus Diseases; Infections; Skin Diseases, Viral; Tumor Virus Infections; Skin Diseases, Infectious; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Glycopeptides; Glycoconjugates; Carbohydrates; Peptides; Amino Acids, Peptides, and Proteins; Antigens, Bacterial; Bacterial Proteins; Proteins; Antigens; Biological Factors

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: March 12, 2018
• First Posted: March 26, 2018
• Study Start: April 1, 2018
• Primary Completion: April 1, 2019
• Study Completion: April 1, 2020
• Last Updated: March 26, 2018

Record last verified: 2018-03