Safety and Efficacy of Hydrocortisone and Lidocaine Treatment of Grade I and II Hemorrhoids

A Randomized, Dose-Ranging, Double Blind Study of Lidocaine Hydrochloride and/or Hydrocortisone Acetate (Alone or in Combination) in the 14-Day Twice-Daily Treatment of Grade I or II Hemorrhoids

The objectives of this study are to assess the potential contribution of lidocaine hydrochloride or hydrocortisone acetate, alone or in combination, in topical cream preparations in the treatment of Grade I or II hemorrhoids and to demonstrate the safety and efficacy of the test articles when applied twice daily for 14 days in subjects with Grade I or II hemorrhoids. These products reflect common drug combinations of lidocaine hydrochloride or hydrocortisone acetate found in many prescription hemorrhoid products.

This is a multi-center, randomized, double-blind, parallel group comparison study in approximately 196 enrolled subjects (~28 subjects/test article) at approximately eight (8) sites. A minimum of 147 patients will be enrolled. Up to an additional 56 subjects (up to 196 subjects) may be enrolled based on enrollment rates and availability of patients. Enrollment status reports will be periodically generated, and based on enrollment experience, additional randomization blocks will be assigned to sites with the potential to enroll additional subjects over a reasonable period of time.

Male and female subjects, ages 18 years and older, with a clinical diagnosis of symptomatic Grade I or Grade II hemorrhoids will be randomized to treatment with one of seven (7) test articles (1:1 for all groups):

1. Vehicle Cream
2. 3% Hydrocortisone Acetate Cream
3. 0.5% Hydrocortisone Acetate Cream
4. 5% Lidocaine Hydrochloride Cream
5. 1% Lidocaine Hydrochloride Cream
6. 3% Hydrocortisone Acetate Cream and 5% Lidocaine Hydrochloride Cream
7. 0.5% Hydrocortisone Acetate Cream and 1% Lidocaine Hydrochloride Cream

The test articles will be applied twice daily for two (2) weeks (14 days) to the peri-rectal area as well as the distal aspect of the anal canal using the product applicator tip.

Inclusion Criteria:

1. Subject is male or non-pregnant female 18 years of age or older, in generally good health. Females must be post-menopausal, surgically sterile or have a negative urine pregnancy test (UPT) at the Baseline Visit and agree to use birth control during the study.
2. Subject has provided written and verbal informed consent.
3. Subject presents to the clinic with clinically confirmed symptomatic Grade I or II hemorrhoids (GSDS ≥ 2).
4. Subject is willing and able to comply with study instructions and return to the clinic for required visits.

Exclusion Criteria:

1. Subject is female and lactating or planning to become pregnant during the study.

2. Subject has anorectal condition(s) such as malignant tumors of the anus or rectum, fistula-in-ano or chronic sepsis, fissure-in-ano, incontinence, condylomata and Grade III and IV hemorrhoids.

3. Subject has a history of previous proctological surgery or has active inflammatory bowel disease.

4. Subject may use stool softeners, but shall be on a stable regimen for at least 28 days prior to enrolling in the study.

5. Subject used the following systemic, oral or topical therapies for the periods specified prior to entry into the study:

   • Within 1 day: Topicals of any kind to the rectal/peri-rectal area.
   • Within 1 week: Over the counter (OTC) or prescription treatments labeled or intended for the treatment of hemorrhoids or that could have a significant effect in the opinion of the investigator including but not limited to steroids, OTC and prescription hemorrhoid products, among others.

6. Subject has a current history of an uncorrected coagulation defect or concurrently uses anticoagulants (except aspirin or non-steroidals).

7. Subject has any skin pathology or condition that could interfere with the evaluation of the test products or requires the use of interfering topical, systemic or surgical therapy.

8. Subject has known hypersensitivity or previous allergic reaction to any of the active or inactive components of the test articles.

9. Subject has any condition which, in the Investigator's opinion, would make it unsafe or preclude the subject's ability to fully participate in this research study.

10. Subject is unable to communicate or cooperate with the Investigator due to language problems, poor mental development, impaired cerebral function or physical limitations.

11. Subject may be unreliable for the study including subjects who engage in excessive alcohol intake or drug abuse, or subjects who are unable to return for scheduled follow-up visits.

12. Subject is currently enrolled in an investigational drug or device study.

13. Subject has received an investigational drug or has been treated with an investigational device within 30 days prior to the initiation of treatment (Baseline).