The effect of Deflagyn vaginal gel in premenopausal women with precancerous changes of the cervix
| ISRCTN | ISRCTN87431813 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN87431813 |
- Submission date
- 21/06/2022
- Registration date
- 12/12/2022
- Last edited
- 14/07/2025
- Recruitment status
- No longer recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English summary of protocol
Background and study aims
The purposes of the study are to assess the effect of the vaginal gel Deflagyn in patients with a finding of abnormal cells (HSIL) that line the outer part of the womb (cervix), and to prove the relationship between cytokines and progression or regression of a cervical lesion (HSIL).
Who can participate?
Women aged between 25 and 50 years old
What does the study involve?
The treatment is conducted according to worldwide standards after 3 months of Deflagyn treatment. There will be no biopsy performed before vaginal gel usage, as we want to see the pure effect of Deflagyn. If a biopsy is undertaken, it will bias the results. Biopsies will be performed after 3 months of vaginal Deflagyn application according to clinical standards if the colposcopy lesion is still visible. Before treatment with Deflagyn the patients will be given a questionnaire with 13 questions to answer about cervical cancer risk.
What are the possible benefits and risks of participating?
A possible benefit of this vaginal gel is that patients will be cleared of HPV and will show a regression of the precancerous lesions. This may avoid the necessity to perform surgical excision of part of the cervix and therefore the full functionality of the cervix will continue.
There are no risks for participants. Only well-defined colposcopic lesions on the ectocervix with a visible squamocolumnar junction are included in the study in order to exclude the risk of invasive cancer.
Where is the study run from?
Medline Clinic (Uzbekistan)
When is the study starting and how long is it expected to run for?
June 2022 to October 2026
Who is funding the study?
1. Investigator initiated and funded
2. Deflamed International S.R.O. (Czechia)
Who is the main contact?
1. Dr Yusupova Shahnoza shahnoza.yusupova90@gmail.com
2. Dr Kudrat Jumaniyozov kudrat.jumaniyazov@minzdrav.uz
Contact information
Principal Investigator
Femina Gynecology Center
Rue Emile-Yung 1
Geneva
1205
Switzerland
 ORCID ID |
0000-0002-1459-2727 |
|---|---|
| Phone | +41 (0)795222440 |
| cabinetfemina@outlook.com |
Scientific
Medline Clinic
Pachlavana Machmuda Street 220
Urgench
220100
Uzbekistan
| ORCID ID |
0000-0001-5668-3144 |
|---|---|
| Phone | +998919853223 |
| kudrat.jumaniyazov@minzdrav.uz |
Scientific
Russian Scientific Center of Radiology and Nuclear Medicine at the Ministry of Public Health of the Russian Federation
Profsoyuznaya Street 86
Moscow
117485
Russian Federation
| ORCID ID |
0000-0002-2076-2016 |
|---|---|
| Phone | +7 (0)9154002440 |
| aleksriger96@mail.ru |
Scientific
Tashkent Medical Academy Urgench branch
Al-Horasmi Street 25
Urgench
220100
Uzbekistan
| ORCID ID |
0000-0002-6889-3701 |
|---|---|
| Phone | +998 (0)972119333 |
| shahnoza.yusupova90@gmail.com |
Study information
| Study design | Prospective cohort study |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Non randomised study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details to request a participant information sheet |
| Scientific title | Cytokines in patients with HSIL, HPV positive >25 years old and <50 years old before and after Deflagyn vaginal gel compared to a control group with normal cytology (NILM) |
| Study objectives | The primary objective is to evaluate the effect of vaginal gel Deflagyn on cytokines. Changes in cytokine levels are analyzed by using a multiplex bead-based immunoassay. The secondary objective is to analyze the effect of vaginal gel Deflagyn on HPV, cytology, colposcopic appearance, bacteriology, methylation analysis and pH in the vagina. |
| Ethics approval(s) | Approved 22/06/2022, Ethical Committee at Tashkent Medical Academy (14, H.Olimjon str, Urgench, Khorezm region, 220100, Uzbekistan; +998 (0)995649170; ttaurgfil@umail.uz), ref: 01/2016 |
| Health condition(s) or problem(s) studied | Local treatment of cervical precancerosis, prevention of cervical cancer |
| Intervention | Local treatment of precancerosis of the cervix with vaginal gel Deflagyn. The control group consists of patients with a normal PAP smear independent of the HPV test. In the study group (HSIL, HPV positive), patients will be treated with intravaginal self-administrated vaginal gel Deflagyn containing 10.0 mg of highly dispersed silicon dioxide, 24.8 mg of citric acid, and 0.25 mg of selenium per administration (5 ml). The vaginal gel should be applied daily, deep inside the vagina using a single-use applicator during 3 × 28-day courses. The sponsor of the investigational device is Deflamed International S.R.O. Before treatment with Deflagyn the patients will be given a questionnaire with 13 questions to answer about cervical cancer risk. |
| Intervention type | Device |
| Pharmaceutical study type(s) | |
| Phase | Not Applicable |
| Drug / device / biological / vaccine name(s) | Deflagyn |
| Primary outcome measure | Cytokine levels measured using multiplex immunoassay on analyzer Luminex 200 System before and after usage of Deflagyn |
| Secondary outcome measures | 1. High-risk human papillomavirus (HR-HPV) positivity measured using PCR before and after treatment with Deflagyn 2. Cervical smear cytology measured using a liquid-based Pap-test before and after treatment with Deflagyn 3. Presence of cervical lesions diagnosed using colposcopy before and after treatment with Deflagyn 4. Lactobacillus in the cervical smear measured using scanning electron microscopy before and after treatment with Deflagyn 5. PH of cervical mucus measured using pH strips before and after treatment with Deflagyn 6. Assessment of cervical cancer risk measured using a questionnaire before treatment with Deflagyn 7. DNA methylation analysis measured using sequencing before and after treatment with Deflagyn |
| Overall study start date | 10/06/2022 |
| Completion date | 24/10/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 25 Years |
| Sex | Female |
| Target number of participants | Target number of participants 77 active with HSIL with Deflagyn treatment and 38 controls with normal cytology without Deflagyn treatment . |
| Key inclusion criteria | 1. HPV+, HSIL and control group 2. Squamo-cylindric junction visible in colposcopy 3. Acetic acid white lesion <50% of the ectocervix 4. Aged 25 years old and over to <50 years old (premenopausal) |
| Key exclusion criteria | 1. Cancer 2. Immunodeficiency (HIV) 3. Smoking 4. Pregnancy 5. Menometrorrhagia 6. Inflammatory and viral genital diseases (syphilis, gonorrhea, adnexitis) |
| Date of first enrolment | 24/12/2022 |
| Date of final enrolment | 24/07/2025 |
Locations
Countries of recruitment
- Uzbekistan
Study participating centres
Urgench
220100
Uzbekistan
Urgench
-
Uzbekistan
Urgench
-
Uzbekistan
Urgench
-
Uzbekistan
Urgench
-
Uzbekistan
Horezm region, Kushkupir district
-
Uzbekistan
Urgench
-
Uzbekistan
Sponsor information
Industry
4 Sayram 7th Passage
Tashkent
100170
Uzbekistan
| Phone | +998 (0)78 150 86 68 |
|---|---|
| info@nikapharm.uz |
Industry
Grundstrasse 12
Rotkreuz
6343
Switzerland
| Phone | +4141 780 60 00, +4141 780 70 66 |
|---|---|
| service@gynial.ch |
Funders
Funder type
Other
No information available
No information available
Results and Publications
| Intention to publish date | 24/04/2027 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publication in a high-impact peer-reviewed journal |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are available from the corresponding authors (Dr Kudrat Jumaniyozov, kudrat.jumaniyazov@minzdrav.uz, Prof Attila Major, cabinetfemina@outlook.com and Dr Aleksandra Riger, riger96@mail.ru) on reasonable request |
Editorial Notes
14/07/2025: The completion date was changed from 24/10/2025 to 24/10/2026.
14/12/2022: Internal review.
04/07/2022: Trial's existence confirmed by The Ministry of Public Health of the Republic of Uzbekistan Tashkent Medical Academy Urgench Branch.
