Intraepithelial Neoplasia, CervicalNCT04859361
Comparison of Treatment of Cervical Intraepithelial Lesions With Imiquimod or LLETZ
A study testing Aldara 5% Topical Cream and LLETZ in people with Intraepithelial Neoplasia, Cervical, run by University Medical Centre Maribor at 1 site in Slovenia.
Trial summary
Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Intraepithelial Neoplasia, Cervical
- What is being tested?
- Aldara 5% Topical Cream and LLETZ
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 104 participants
- Where
- 1 siteSlovenia
- Study dates
- 20 Nov 2018to 15 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- newly diagnosed and previously untreated HSIL in women aged 18 to 35 years or up to 40 years in case of nulliparity;
- satisfactory colposcopy (i.e., fully visible lesion and transformation zone);
- negative pregnancy test;
- safe contraception;
- signed, informed consent.
Who cannot join
- previously diagnosed HSIL or AIS;
- previous LLETZ or classical conisation;
- concomitant vulvar or vaginal lesion or neoplasia;
- other malignancies;
- insufficient colposcopy;
- pregnancy or lactation;
Show all 11Show fewer
- known hypersensitivity to imiquimod;
- any known contraindications to immunotherapy;
- known HIV or acute or chronic hepatitis;
- immune deficiency;
- participation in any other ongoing clinical trial.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of Conservative Treatment of Cervical Intraepithelial Lesions With Imiquimod With Standard Excisional Technique Using LLETZ: a Randomized Controlled Trial
Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. LLETZ as standard treatment is possibly associated with premature labour, higher subfertility rate and a higher rate of spontaneous abortion. Since premature delivery is one of the most important causes of perinatal morbidity and mortality, alternative conservative methods for SIL treatment are constantly being evaluated. The immunomodulator imiquimod is one of the main target compounds for treating HSIL.
Primary objective: to establish the efficacy of treatment with imiquimod (experimental arm) and compare it to the standard treatment with LLETZ (control arm).
Read more
Secondary objective:
- incidence and severity of the side effects in both groups;
- need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm;
- modulatory effect of imiquimod on immunoregulatory molecules.
Study design: Single-centre randomized controlled intervention trial.
Study population: 104 women with HSIL (52 in each arm).
Intervention:
- randomization in two arms:
- Experimental arm (imiquimod): treatment for 16 weeks with 5% imiquimod.
- Control arm (LLETZ).
Successful treatment in the experimental arm is defined as absence of histological HSIL in diagnostic biopsies at 20-week follow-up (4 weeks after treatment completion) and in the control arm successful treatment is defined as absence of cytological HSIL in cytology 6 months after LLETZ (same as in our national guidelines).
Read the detailed description
Imiquimod is one of the target topical drugs for treating HSIL. It is a Toll-like receptor 7 agonist that acts locally so that it induces cellular response, which can aid in the regression of HPV-associated lesions. Imiquimod is currently used for treating genital warts. In vitro studies have shown promising effects in the treatment of several diseases, such as endometrial, cervical and prostate cancer, endometriosis, melanoma, and cervical and vulvar intraepithelial lesions. Clinical studies are however lacking. With this in mind, the aim of our study was to evaluate whether topical treatment of HSIL with imiquimod is comparable to standard treatment with LLETZ. As mentioned in the Brief summary, we have set different outcome measures in the experimental and control arm. The different outcome measures were based on moderate accuracy of PAP smear, therefore in order to minimize potential progression of cervical disease to cancer and to avoid LLETZ and possible overtreatment and to assess as accurately as possible the potential residual disease, colposcopy with biopsies will be performed 4 weeks after treatment with imiquimod is completed (20th week after treatment initiation). Follow up after LLETZ will performed using cytology (PAP smear), which is in concordance with our national guidelines. Biopsies will be performed in case of clinically visible lesions. Secondary outcomes of the study are the incidence and severity of the side effects in both groups, which will be evaluated during and after treatment using the 5th version of the Common Terminology Criteria for Adverse Events (CTCAE) guidelines. Other secondary outcomes, namely the need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm, respectively, and the modulatory effect of imiquimod on immunoregulatory molecules are expected to be available in three years' time after treatment is completed in all patients in both arms.
- Conditions
- Intraepithelial Neoplasia, Cervical
- Being tested
- Aldara 5% Topical Cream, LLETZ
- Keywords
- imiquimod, LLETZ, cervical intraepithelial lesion
- Medical subject headings
- Uterine Cervical Dysplasia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aldara 5% Topical CreamDrug
Also called Zyclara, imiquimod
5% Imiquimod cream (1 sachet) will be administered via menstrual cup, before going to sleep, 3 times per week for 16 weeks. Menstrual cup will be inserted in the vagina for a duration of 6-8 hours. In case of severe side effects applications can be reduced to twice per week and if side effects are persistent, to once per week. For maximum control of cervical disease, control colposcopy with a PAP smear and a punch biopsy will be scheduled at 10 weeks to rule out progression, and at 20 weeks after treatment initiation to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present, and if there are any new lesions present, additional biopsies will be performed. In case of disease progression or persistence, treatment with LLETZ will be offered.
LLETZProcedure or surgery
Also called LEEP
LLETZ will be performed in an outpatient setting with local anesthesia, using KLS Martin Maxium with loop devices ranging from 10 mm to 20 mm in size. The excision will be performed using monopolar current with a cut frequency set to 100-150 W. Treatment success will be evaluated in accordance with our national guidelines 24 weeks after the procedure using a PAP smear with or without a punch biopsy.
| Study group | Role | What they receive |
|---|---|---|
| Treatment with imiquimod | Experimental | Colposcopy with PAP smear and punch biopsy is scheduled at 10 weeks to rule out progression, and at 20 weeks to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present and additional biopsies will be performed on any visible lesions. At 20 weeks, in case of disease progression or persistence, treatment with LLETZ will be offered. Receives: Drug: Aldara 5% Topical Cream |
| Treatment with LLETZ | Active comparator | Standard treatment will be scheduled after patients' first period. Receives: Procedure: LLETZ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment efficacy of 5% imiquimod cream for treatment of HSIL compared to standard treatment with LLETZ defined as absence of HSIL in both arms (histological in experimental arm and cytological in control arm).
Defined as following:
- for experimental (imiquimod) treatment arm: absence of histological HSIL (CIN1 or less) in diagnostic biopsies at colposcopy at 20 weeks;
- for control (LLETZ) arm: absence of cytological HSIL at 6 months follow-up.
Measured: 20 weeks after treatment initiation in experimental arm and 6 months after LLETZ in control arm.
Secondary outcomes (3)
Prevalence and severity of the side effects in both arms.
Incidence and severity of side effects scored by the 5th version of the Common Terminology Criteria for Adverse Events (CTCAE) guidelines.
Measured: 10 weeks and 20 weeks after treatment initiation in experimental arm and 20 weeks after LLETZ in control arm.
Need for LLETZ or repeated LLETZ following primary treatment.
The need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm
Measured: 2 years after primary treatment.
Immunoregulatory effect of imiquimod.
Modulatory effect of imiquimod on immunoregulatory molecules.
Measured: 2 years after primary treatment.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Apr 2021
- Study start20 Nov 2018
- Primary completion21 Apr 2020
- Study completion15 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Intraepithelial Neoplasia, CervicalStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 104 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Medical Centre Maribor
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04859361
- Sponsor's protocol ID
- 2017-01-02
- Status last verified
- Apr 2021
- First submitted
- 21 Apr 2021
- Last updated
- 3 May 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
PubMed 22914404de Witte CJ, van de Sande AJ, van Beekhuizen HJ, Koeneman MM, Kruse AJ, Gerestein CG. Imiquimod in cervical, vaginal and vulvar intraepithelial neoplasia: a review. Gynecol Oncol. 2015 Nov;139(2):377-84. doi: 10.1016/j.ygyno.2015.08.018. Epub 2015 Aug 31.
PubMed 26335596Koeneman MM, Kruse AJ, Kooreman LFS, Zur Hausen A, Hopman AHN, Sep SJS, Van Gorp T, Slangen BFM, van Beekhuizen HJ, van de Sande M, Gerestein CG, Nijman HW, Kruitwagen RFPM. TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial. BMC Cancer. 2016 Feb 20;16:132. doi: 10.1186/s12885-016-2187-3.
PubMed 26897518Jancar N, Mihevc Ponikvar B, Tomsic S. Cold-knife conisation and large loop excision of transformation zone significantly increase the risk for spontaneous preterm birth: a population-based cohort study. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:245-9. doi: 10.1016/j.ejogrb.2016.06.005. Epub 2016 Jun 20.
PubMed 27359080Cokan A, da Silva NCH, Kavalar R, But I, Pakiz M, Andrade de Oliveira S, Dos Santos Gomes FO, da Silva RS, Peixoto CA, Lucena-Silva N. Modulation of sHLA-G, PD-1, and PD-L1 Expression in Cervical Lesions Following Imiquimod Treatment and Its Association with Treatment Success. Cancers (Basel). 2024 Mar 25;16(7):1272. doi: 10.3390/cancers16071272.
PubMed 38610950
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Conservative Treatment of Cervical Intraepithelial Lesions With Imiquimod With Standard Excisional Technique Using LLETZ: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT04859361
- Acronym / sponsor ID
- 2017-01-02
- Conditions
- Intraepithelial Neoplasia, Cervical
- Keywords
- imiquimod, LLETZ, cervical intraepithelial lesion
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 104 participants (actual)
- Lead sponsor
- University Medical Centre MariborUniversity, hospital or other
- Study start
- 20 Nov 2018 (actual)
- Primary completion
- 21 Apr 2020 (actual)
- Study completion
- 15 Sep 2023 (estimated)
- First posted
- 26 Apr 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Purpose: There are limited data on the success of conservative treatment of high-grade cervical squamous intraepithelial lesions (HSIL) with imiquimod directly compared to standard of treatment with LLETZ. LLETZ as standard treatment is possibly associated with premature labour, higher subfertility rate and a higher rate of spontaneous abortion. Since premature delivery is one of the most important causes of perinatal morbidity and mortality, alternative conservative methods for SIL treatment are constantly being evaluated. The immunomodulator imiquimod is one of the main target compounds for treating HSIL.
Primary objective: to establish the efficacy of treatment with imiquimod (experimental arm) and compare it to the standard treatment with LLETZ (control arm).
Secondary objective:
- incidence and severity of the side effects in both groups;
- need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm;
- modulatory effect of imiquimod on immunoregulatory molecules.
Study design: Single-centre randomized controlled intervention trial.
Study population: 104 women with HSIL (52 in each arm).
Intervention:
- randomization in two arms:
- Experimental arm (imiquimod): treatment for 16 weeks with 5% imiquimod.
- Control arm (LLETZ).
Successful treatment in the experimental arm is defined as absence of histological HSIL in diagnostic biopsies at 20-week follow-up (4 weeks after treatment completion) and in the control arm successful treatment is defined as absence of cytological HSIL in cytology 6 months after LLETZ (same as in our national guidelines).
Detailed description
Imiquimod is one of the target topical drugs for treating HSIL. It is a Toll-like receptor 7 agonist that acts locally so that it induces cellular response, which can aid in the regression of HPV-associated lesions. Imiquimod is currently used for treating genital warts. In vitro studies have shown promising effects in the treatment of several diseases, such as endometrial, cervical and prostate cancer, endometriosis, melanoma, and cervical and vulvar intraepithelial lesions. Clinical studies are however lacking. With this in mind, the aim of our study was to evaluate whether topical treatment of HSIL with imiquimod is comparable to standard treatment with LLETZ. As mentioned in the Brief summary, we have set different outcome measures in the experimental and control arm. The different outcome measures were based on moderate accuracy of PAP smear, therefore in order to minimize potential progression of cervical disease to cancer and to avoid LLETZ and possible overtreatment and to assess as accurately as possible the potential residual disease, colposcopy with biopsies will be performed 4 weeks after treatment with imiquimod is completed (20th week after treatment initiation). Follow up after LLETZ will performed using cytology (PAP smear), which is in concordance with our national guidelines. Biopsies will be performed in case of clinically visible lesions. Secondary outcomes of the study are the incidence and severity of the side effects in both groups, which will be evaluated during and after treatment using the 5th version of the Common Terminology Criteria for Adverse Events (CTCAE) guidelines. Other secondary outcomes, namely the need for treatment with LLETZ two years after primary treatment with imiquimod in the experimental arm or re-treatment with LLETZ two years after primary treatment with LLETZ in the control arm, respectively, and the modulatory effect of imiquimod on immunoregulatory molecules are expected to be available in three years' time after treatment is completed in all patients in both arms.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment with imiquimod | Experimental | Drug: Aldara 5% Topical CreamColposcopy with PAP smear and punch biopsy is scheduled at 10 weeks to rule out progression, and at 20 weeks to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present and additional biopsies will be performed on any visible lesions. At 20 weeks, in case of disease progression or persistence, treatment with LLETZ will be offered. |
| Treatment with LLETZ | Active comparator | Procedure: LLETZStandard treatment will be scheduled after patients' first period. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- newly diagnosed and previously untreated HSIL in women aged 18 to 35 years or up to 40 years in case of nulliparity;
- satisfactory colposcopy (i.e., fully visible lesion and transformation zone);
- negative pregnancy test;
- safe contraception;
- signed, informed consent.
Key exclusion criteria (11 listed)
- previously diagnosed HSIL or AIS;
- previous LLETZ or classical conisation;
- concomitant vulvar or vaginal lesion or neoplasia;
- other malignancies;
- insufficient colposcopy;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aldara 5% Topical CreamAlso: Zyclara, imiquimod5% Imiquimod cream (1 sachet) will be administered via menstrual cup, before going to sleep, 3 times per week for 16 weeks. Menstrual cup will be inserted in the vagina for a duration of 6-8 hours. In case of severe side effects applications can be reduced to twice per week and if side effects are persistent, to once per week. For maximum control of cervical disease, control colposcopy with a PAP smear and a punch biopsy will be scheduled at 10 weeks to rule out progression, and at 20 weeks after treatment initiation to evaluate treatment success. At 20 weeks, biopsies will be performed at the locations where lesions were previously present, and if there are any new lesions present, additional biopsies will be performed. In case of disease progression or persistence, treatment with LLETZ will be offered. | Drug | Treatment with imiquimod |
| LLETZAlso: LEEPLLETZ will be performed in an outpatient setting with local anesthesia, using KLS Martin Maxium with loop devices ranging from 10 mm to 20 mm in size. The excision will be performed using monopolar current with a cut frequency set to 100-150 W. Treatment success will be evaluated in accordance with our national guidelines 24 weeks after the procedure using a PAP smear with or without a punch biopsy. | Procedure or surgery | Treatment with LLETZ |
Primary outcome
Treatment efficacy of 5% imiquimod cream for treatment of HSIL compared to standard treatment with LLETZ defined as absence of HSIL in both arms (histological in experimental arm and cytological in control arm).
Time frame: 20 weeks after treatment initiation in experimental arm and 6 months after LLETZ in control arm.
Defined as following: * for experimental (imiquimod) treatment arm: absence of histological HSIL (CIN1 or less) in diagnostic biopsies at colposcopy at 20 weeks; * for control (LLETZ) arm: absence of cytological HSIL at 6 months follow-up.
3 secondary outcomes
Prevalence and severity of the side effects in both arms.
Time frame: 10 weeks and 20 weeks after treatment initiation in experimental arm and 20 weeks after LLETZ in control arm.
Need for LLETZ or repeated LLETZ following primary treatment.
Time frame: 2 years after primary treatment.
Immunoregulatory effect of imiquimod.
Time frame: 2 years after primary treatment.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2021.
- Background: PubMed 22914404Grimm C, Polterauer S, Natter C, Rahhal J, Hefler L, Tempfer CB, Heinze G, Stary G, Reinthaller A, Speiser P. Treatment of cervical intraepithelial neoplasia with topical imiquimod: a randomized controlled trial. Obstet Gynecol. 2012 Jul;120(1):152-9. doi: 10.1097/AOG.0b013e31825bc6e8.
- Background: PubMed 26335596de Witte CJ, van de Sande AJ, van Beekhuizen HJ, Koeneman MM, Kruse AJ, Gerestein CG. Imiquimod in cervical, vaginal and vulvar intraepithelial neoplasia: a review. Gynecol Oncol. 2015 Nov;139(2):377-84. doi: 10.1016/j.ygyno.2015.08.018. Epub 2015 Aug 31.
- Background: PubMed 26897518Koeneman MM, Kruse AJ, Kooreman LFS, Zur Hausen A, Hopman AHN, Sep SJS, Van Gorp T, Slangen BFM, van Beekhuizen HJ, van de Sande M, Gerestein CG, Nijman HW, Kruitwagen RFPM. TOPical Imiquimod treatment of high-grade Cervical intraepithelial neoplasia (TOPIC trial): study protocol for a randomized controlled trial. BMC Cancer. 2016 Feb 20;16:132. doi: 10.1186/s12885-016-2187-3.
- Background: PubMed 27359080Jancar N, Mihevc Ponikvar B, Tomsic S. Cold-knife conisation and large loop excision of transformation zone significantly increase the risk for spontaneous preterm birth: a population-based cohort study. Eur J Obstet Gynecol Reprod Biol. 2016 Aug;203:245-9. doi: 10.1016/j.ejogrb.2016.06.005. Epub 2016 Jun 20.
- Derived from this study: PubMed 38610950Cokan A, da Silva NCH, Kavalar R, But I, Pakiz M, Andrade de Oliveira S, Dos Santos Gomes FO, da Silva RS, Peixoto CA, Lucena-Silva N. Modulation of sHLA-G, PD-1, and PD-L1 Expression in Cervical Lesions Following Imiquimod Treatment and Its Association with Treatment Success. Cancers (Basel). 2024 Mar 25;16(7):1272. doi: 10.3390/cancers16071272.
Related trials for Intraepithelial Neoplasia, Cervical
RecruitingObservational study
Role of Liquid Biopsies in HPV-associated Cancer Treatment Monitoring
Cervical Cancer, Cervical Dysplasia
RecruitingObservational study
Leveraging Methylated DNA Markers (MDMs) in the Detection of Endometrial Cancer, Ovarian Cancer, and Cervical Cancer
Endometrial Cancer, Cervical Cancer
Recruiting
Feasibility Study Comparing Use of One Or Two Probes for Thermal Ablation Among Screen Positive Women Living With HIV in C1001P-CS2 Kenya
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for Thermal Ablation Among Cervical Cancer Screen Positive WLWH in C1001P-CS9 South Africa
HIV (Human Immunodeficiency Virus), HPV
Recruiting
Feasibility Study Comparing One vs Two Probes for TA Among Cervical Cancer Screen Positive WLWH in C1001P-CS5 Rwanda
HIV (Human Immunodeficiency Virus), HPV
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aldara 5% Topical Cream and LLETZ in people with Intraepithelial Neoplasia, Cervical, run by University Medical Centre Maribor at 1 site in Slovenia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Slovenia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment efficacy of 5% imiquimod cream for treatment of HSIL compared to standard treatment with LLETZ defined as absence of HSIL in both arms (histological in experimental arm and cytological in control arm). (time frame: 20 weeks after treatment initiation in experimental arm and 6 months after LLETZ in control arm.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04859361, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 May 2021.