Comparisons of the Effects and Clinical Outcomes of CH2 Vaginal Gel Versus Placebo on CIN1

NCT06582004 | Active Not Recruiting

• 1 other identifier: 202405043RSD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

In Taiwan, Pap smear screen has been offered every year for women over 30 years old since 1995. The incidence of cervical invasive cancer decreased from 25/100,000 person in 1995 to 7.0/100,1000 person in 2016. In contrast, the incidence of pre-cancerous lesions increased gradually. According to ASCCP, observation and repeated cytology in 6-12 months is recommended in colposcopy-diagnosed CIN1 patients. Most of the low-grade lesions regressed spontaneously without treatment; 49 percent of CIN1 regressed to negative in six months, and 70 percent regressed in 12 months. Emerging evidence suggests associations between the composition of the vaginal microbiota (VMB), human papillomavirus (HPV) infection, and cervical intraepithelial neoplasia (CIN). Previous research included 87 patients with untreated CIN2. It reported that patients with a Lactobacillus-dominant microbiome at baseline are more likely to have regressive disease at 12 months. Lactobacillus spp. depletion and presence of specific anaerobic taxa are associated with CIN2 persistence and slower regression. 82.9 percent of women with low-grade squamous intraepithelial lesions (LSIL) tested positive for HPV. CH2 vaginal gel is a marketed health product derived from natural ingredients, including water, probiotic glycerol, and plant extracts. Investigators have designed this trial to compare the following outcomes between participants who use and those who use placebo: 1. the regression rate of CIN1, 2. the time to regression of CIN1, and 3. the HPV clearance rate in participants.

Conditions

Cervical Intraepithelial Neoplasia; Human Papillomavirus

Outcome Measures

Primary Outcomes (1)

• pap smear result

  Thinprep smear every 3 months. The report from thinprep smear and coloposcope examination. Data will be categorized as CIN1, CIN2 and above, inflammation, normal.

  up to 9 months

Secondary Outcomes (1)

• HPV clearance rate

  up to 9 months

Study Arms (2)

Placebo

PLACEBO COMPARATOR

use vaginal hyaluronic acid gel as placebo

Dietary Supplement: Placebo hyaluronic acid gel

CH2 vaginal gel

EXPERIMENTAL

use CH2 vaginal gel as intervention The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks

Dietary Supplement: CH2 vaginal gel

Interventions

CH2 vaginal gel DIETARY_SUPPLEMENT

The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks

CH2 vaginal gel

Placebo hyaluronic acid gel DIETARY_SUPPLEMENT

The usage frequency is 2 units per week, with a 3-day interval between each unit, for a total duration of 24 weeks

Placebo

Eligibility Criteria

• Age: 20 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Female individuals aged 20 years (inclusive) or older who have abnormal Pap smear results and have been diagnosed with CIN1 via colposcopy biopsy, and are also positive for high-risk HPV. This includes:
• Patients with Pap smear results of CIN2, ASCUS, or CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, with pathology confirming CIN1.
• Patients with Pap smear results of CIN1 who have undergone colposcopic biopsy of suspicious lesions or random biopsies, and where the biopsy sample is insufficient for diagnosis or the biopsy pathology is normal.

You may not qualify if:

• Female patients who are currently pregnant, planning to become pregnant, or are underage.
• Patients with an allergy to the ingredients in CH2 Natural Purifying Protection Serum.
• Patients diagnosed with CIN2, CIN3, or higher through colposcopic biopsy.
• Patients with urinary tract or pelvic infections.
• Patients with significantly impaired cognitive function.
• Patients who are unable to self-administer vaginal gel.
• Patients with immunocompromised conditions, end-stage liver or kidney disease, those using steroids, or those who have previously undergone total hysterectomy.

Sponsors & Collaborators

• National Taiwan University Hospital: lead

Study Sites (1)

National Taiwan University Hospital

Taipei City, Taipei, 110, Taiwan

Location

MeSH Terms

Conditions

Uterine Cervical Dysplasia

Condition Hierarchy (Ancestors)

Precancerous Conditions; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Study Officials

• Chi Hau Chen

  National Taiwan University Hospsital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 26, 2024
• First Posted: September 3, 2024
• Study Start: September 30, 2024
• Primary Completion: January 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

TW (1)