A Trial of the Efficacy and Safety of Topical Nitric Oxide in Patients With Anogenital Warts

NCT ID: NCT02015260

Last Updated: 2017-05-03

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 299 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2001-09-30
• Study Completion Date: 2003-05-31

Brief Summary

Objective To assess the efficacy of the topical application of Nitric Oxide, delivered using acidified nitrite.

Design Multicentre, randomized, controlled, dose ranging trial. A control arm and three doses of acidified nitrite applied topically for 12 weeks with a further 12 weeks of follow up.

Setting The trial setting was in European genitourinary medicine clinics

Participants Male and female volunteers over 18 years of age with between 2 and 50 ano-genital warts, 328 were screened for eligibility and 299 subjects from 40 centres were randomised.

Exclusions Pregnancy; concomitant Sexually Transmitted Disease; internal warts requiring treatment other than surgery /laser; diabetes ; Human Immunodeficiency Virus-positive, immunosuppressed and/or using immunosuppressive therapies; drug abuse.

interventions compared

• Control Placebo nitrite cream and placebo citric acid cream twice daily
• A) 3% sodium nitrite + 4.5% citric acid creams twice daily
• B) 6% sodium nitrite + 9% citric acid creams once daily
• C) 6% sodium nitrite + 9% citric acid creams twice daily

Outcomes

• Primary proportion of patients with complete clearance of target warts Secondary
• Time to clearance
• Wart area
• Wart count
• Patient and investigator assessment of efficacy
• Safety
• Tolerability
• Adherence

Conditions

Anogenital Warts; Condylomata Acuminata

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

placebo

placebo 0% nitrite cream and placebo 0% citric acid cream

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

Placebo

Topical NO Dose A

3% sodium nitrite + 4.5% citric acid twice daily

Group Type: ACTIVE_COMPARATOR

Topical NO

Intervention Type: DRUG

Varying doses of sodium nitrite and citric acid co-applied to warts

Topical NO Dose B

6% sodium nitrite + 9% citric acid once daily

Group Type: ACTIVE_COMPARATOR

Topical NO

Intervention Type: DRUG

Varying doses of sodium nitrite and citric acid co-applied to warts

Topical NO Dose C

6% sodium nitrite + 9% citric acid twice daily

Group Type: ACTIVE_COMPARATOR

Topical NO

Intervention Type: DRUG

Varying doses of sodium nitrite and citric acid co-applied to warts

Interventions

Topical NO

Varying doses of sodium nitrite and citric acid co-applied to warts

Intervention Type: DRUG

Placebo

Placebo

Intervention Type: DRUG

Other Intervention Names

Acidified Nitrite vs Placebo; Placebo nitrite cream and placebo citric acid cream

Eligibility Criteria

Inclusion Criteria

• Males and females over 18 years of age
• 2-50 warts in the anogenital region.
• Female patients of child-bearing potential had to be willing to use a non-barrier method of contraception at entry and for the duration of the study.
• all patients had to be willing to use barrier protection for the duration of the study.
• All patients had to be able to comply with the requirements of the protocol and be likely to return for follow-up visits and had to be contactable for the duration of the study.

Exclusion Criteria

• Patients with clinically relevant abnormal haematology or biochemistry results (determined from the sample taken at Visit 1).
• Patients who had used an active therapy for anogenital warts within 2 weeks of randomisation to study drug, i.e. Visit 2.
• Patients who had used any local supportive medication, including topical corticosteroids or beta-interferon, within 2 weeks of study entry.
• Patients who had used medication known to adversely affect their haematology profile, including local anaesthetics (benzocaine, lidocaine, etc), nitrofurantoin, sulphonylureas and sulphonamides within 2 weeks of study entry. [Word 'adversely' added by Protocol Amendment 2, 7 May 2002.]
• Patients with abnormal anogenital skin, such as eczema, or skin that had not healed following surgery (cryosurgery, laser ablation or similar).
• Patients who were known to have a concomitant sexually transmitted disease that inhibited accurate assessment of their warts.
• Patients who required treatment other than surgery or laser for internal warts.
• Male patients with intra-urethral warts [deleted by Protocol Amendment 2, 7 May 2002].
• Patients with diabetes (Type I or Type II diabetes).
• Patients who were known to be HIV-positive.
• Patients who were known to be immunosuppressed and/or using immunosuppressive therapies.
• Patients known to abuse alcohol and/or drugs or with a history of chronic alcohol or drug abuse.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kyowa Kirin Co., Ltd.

INDUSTRY

Sponsor Role: collaborator

Erasmus Medical Center

OTHER

Sponsor Role: collaborator

University of Aberdeen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Willem I Van der Meijden

Role: PRINCIPAL_INVESTIGATOR

Erasmus Medical Centre

References

Ormerod AD, van Voorst Vader PC, Majewski S, Vanscheidt W, Benjamin N, van der Meijden W. Evaluation of the Efficacy, Safety, and Tolerability of 3 Dose Regimens of Topical Sodium Nitrite With Citric Acid in Patients With Anogenital Warts: A Randomized Clinical Trial. JAMA Dermatol. 2015 Aug;151(8):854-61. doi: 10.1001/jamadermatol.2015.0381.

Reference Type: DERIVED

PMID: 25922903 (View on PubMed)

Other Identifiers

ANA/2/C

Identifier Type: -

Identifier Source: org_study_id