Human Papilloma VirusPhase 2NCT07072065
Impact Of Intralesional Tuberculin Ppd Injection On Anogenital
A Phase 2 study testing protein purified derivative in people with Human Papilloma Virus and Infections, run by Universitas Padjadjaran at 1 site in Indonesia.
Trial summary
This clinical study investigates the immunological effects of tuberculin purified protein derivative (TPPD) therapy in patients with anogenital warts (AGW) caused by human papillomavirus (HPV). Read more about this study
- Who is it for?
- Ages 12 years and older
- Conditions the study is for
- Human Papilloma Virus, Infections
- What is being tested?
- protein purified derivative
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteIndonesia
- Study dates
- 1 Apr 2022to 31 Jul 2023
- Phase
- Phase 2
- 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 12 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Patients with HPV infection in the anogenital area.
- Prior positive response to a 2 TU (0.1 mL) intradermal PPD antigen injection on the left forearm, indicated by a minimum induration of 5 mm within 48-72 hours.
- Age 12 years or older.
Who cannot join
- History of severe hypersensitivity reactions (e.g., anaphylaxis) to PPD antigen.
- Pregnant or breastfeeding women.
- Received any other AGW treatments within the past 2-3 months.
- Immunosuppressive conditions or currently taking immunosuppressive medications.
- History of asthma or other allergic conditions.
- Presence of active infections or other systemic illnesses.
- History of keloids or seizures.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Venereology Clinic, Dr. Hasan Sadikin Hospital
Bandung, West Java, 40161
About this study
Official title: Impact of Intralesional Tuberculin PPD Injection on Anogenital Warts: Interferon-Α, Interleukin-2, And Treatment Outcomes
This clinical study investigates the immunological effects of tuberculin purified protein derivative (TPPD) therapy in patients with anogenital warts (AGW) caused by human papillomavirus (HPV).
Twelve AGW patients received intralesional TPPD injections (5 tuberculin units) once weekly for six weeks and were compared with twelve control patients.
Read more
Tissue samples were collected at baseline and after two injections for immunohistochemical analysis of interferon-alpha (IFN-α) and interleukin-2 (IL-2) expression.
Blood samples were collected at baseline and after six injections to measure serum levels of IFN-α and IL-2 using ELISA.
The study aims to evaluate TPPD as a potential immunotherapeutic agent by assessing cytokine responses associated with AGW regression.
Read the detailed description
The research was conducted, in the STIs clinic at the Department of Dermatology and Venereology, Dr. Hasan Sadikin Hospital Bandung. The specimen was taken from 12 patients with AGW who have been previously treated with TPPD intralesional therapy, and 12 patients with AGW which not treated with TPPD as a control, from previous research titled which has received ethical clearance from Dr. Hasan Sadikin Hospital Bandung No. LB.02.01/X.6.5/291/2019.
The research inclusion criteria include specimen taken from patient with HPV infection in the anogenital area who have previously demonstrated a response to a 2 TU (0.1 ml) intradermal PPD antigen injection on the left forearm, with a minimum induration of 5 mm observed within 48-72 hours, and patients who were 12 years of age or older. Exclusion criteria include specimen from patient with a history of severe hypersensitivity reactions, such as anaphylaxis, to PPD antigen; pregnant or breastfeeding women; or who have received any other AGW treatments in the two to three months prior; those with immunosuppressive conditions or those who are taking immunosuppressive medications; patients with a history of asthma or other allergic conditions, as well as those experiencing active infections or other systemic illnesses; and patients with a history of keloids or seizures. The PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. The technique involved positioning the syringe needle parallel to the skin surface, with the bevel facing upward. Evaluation of IFN-α and IL-2 expression was performed on AGW tissue and serum samples from AGW patients in the TPPD-treated group, both before and after therapy. Tissue cytokine expression was assessed after the second injection (week 2), while serum cytokine levels were measured after the sixth injection (week 6)
- Conditions
- Human Papilloma Virus, Infections
- Being tested
- protein purified derivative
- Medical subject headings
- Infections
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
protein purified derivativeDrug
tuberculin purified protein derivative with dose 5 tuberculin unit
| Study group | Role | What they receive |
|---|---|---|
| AGW patient treated with PPD antigen injection | Experimental | The PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. Receives: Drug: protein purified derivative |
| AGW patient | No intervention | Lesion observation for 6 week |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)
Quantification of IFN-α positive lymphocytes in anogenital wart (AGW) tissue samples using immunohistochemistry. The average number of IFN-α positive cells will be calculated from three high-power fields (400× magnification).
Measured: Baseline and Week 2
Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC)
Quantification of IL-2 positive lymphocytes in AGW tissue samples using immunohistochemistry. Results are expressed as the mean number of positive cells across three high-power fields
Measured: Baseline and Week 2
Percentage Reduction in AGW Lesion Volume
Lesion volume reduction calculated using the formula:
[(Baseline Volume - Volume at Week 6) / Baseline Volume] × 100%.
Therapeutic response will be classified as:
No response: 0% reduction
Minimal response: <50% reduction
Partial response: 50-99% reduction
Complete response: 100% reduction
Measured: Baseline to Week 6
Change in Serum IFN-α Levels (Measured by ELISA)
Concentration of IFN-α in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
Measured: Baseline and Week 6
Change in Serum IL-2 Levels (Measured by ELISA)
Concentration of IL-2 in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
Measured: Baseline and Week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2025
- Study start1 Apr 2022
- Primary completion31 Mar 2023
- Study completion31 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Human Papilloma VirusStudies 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 2
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Padjadjaran
- Sponsor type
- University, hospital or other
- Collaborators
- National University of Malaysia
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07072065
- Sponsor's protocol ID
- DV-202506.02
- Status last verified
- Jul 2025
- First submitted
- 20 Jun 2025
- Last updated
- 18 Jul 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Intralesional Tuberculin PPD Injection on Anogenital Warts: Interferon-Α, Interleukin-2, And Treatment Outcomes
- ClinicalTrials.gov ID
- NCT07072065
- Acronym / sponsor ID
- DV-202506.02
- Conditions
- Human Papilloma Virus, Infections
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Universitas PadjadjaranUniversity, hospital or other
- Collaborators
- National University of Malaysia
- Study start
- 1 Apr 2022 (actual)
- Primary completion
- 31 Mar 2023 (actual)
- Study completion
- 31 Jul 2023 (actual)
- First posted
- 18 Jul 2025 (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.
This clinical study investigates the immunological effects of tuberculin purified protein derivative (TPPD) therapy in patients with anogenital warts (AGW) caused by human papillomavirus (HPV).
Twelve AGW patients received intralesional TPPD injections (5 tuberculin units) once weekly for six weeks and were compared with twelve control patients.
Tissue samples were collected at baseline and after two injections for immunohistochemical analysis of interferon-alpha (IFN-α) and interleukin-2 (IL-2) expression.
Blood samples were collected at baseline and after six injections to measure serum levels of IFN-α and IL-2 using ELISA.
The study aims to evaluate TPPD as a potential immunotherapeutic agent by assessing cytokine responses associated with AGW regression.
Detailed description
The research was conducted, in the STIs clinic at the Department of Dermatology and Venereology, Dr. Hasan Sadikin Hospital Bandung. The specimen was taken from 12 patients with AGW who have been previously treated with TPPD intralesional therapy, and 12 patients with AGW which not treated with TPPD as a control, from previous research titled which has received ethical clearance from Dr. Hasan Sadikin Hospital Bandung No. LB.02.01/X.6.5/291/2019.
The research inclusion criteria include specimen taken from patient with HPV infection in the anogenital area who have previously demonstrated a response to a 2 TU (0.1 ml) intradermal PPD antigen injection on the left forearm, with a minimum induration of 5 mm observed within 48-72 hours, and patients who were 12 years of age or older. Exclusion criteria include specimen from patient with a history of severe hypersensitivity reactions, such as anaphylaxis, to PPD antigen; pregnant or breastfeeding women; or who have received any other AGW treatments in the two to three months prior; those with immunosuppressive conditions or those who are taking immunosuppressive medications; patients with a history of asthma or other allergic conditions, as well as those experiencing active infections or other systemic illnesses; and patients with a history of keloids or seizures. The PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. The technique involved positioning the syringe needle parallel to the skin surface, with the bevel facing upward. Evaluation of IFN-α and IL-2 expression was performed on AGW tissue and serum samples from AGW patients in the TPPD-treated group, both before and after therapy. Tissue cytokine expression was assessed after the second injection (week 2), while serum cytokine levels were measured after the sixth injection (week 6)
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| AGW patient treated with PPD antigen injection | Experimental | Drug: protein purified derivativeThe PPD group received intralesional TPPD therapy, administering 5 TU (0,25 ml of PPD-2TU) to the largest AGW lesion once a week for six consecutive injections. |
| AGW patient | No intervention | –Lesion observation for 6 week |
Who may qualify
- Ages
- 12 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with HPV infection in the anogenital area.
- Prior positive response to a 2 TU (0.1 mL) intradermal PPD antigen injection on the left forearm, indicated by a minimum induration of 5 mm within 48-72 hours.
- Age 12 years or older.
Key exclusion criteria (7 listed)
- History of severe hypersensitivity reactions (e.g., anaphylaxis) to PPD antigen.
- Pregnant or breastfeeding women.
- Received any other AGW treatments within the past 2-3 months.
- Immunosuppressive conditions or currently taking immunosuppressive medications.
- History of asthma or other allergic conditions.
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 |
|---|---|---|
| protein purified derivativetuberculin purified protein derivative with dose 5 tuberculin unit | Drug | AGW patient treated with PPD antigen injection |
Primary outcome
Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC)
Time frame: Baseline and Week 2
Quantification of IFN-α positive lymphocytes in anogenital wart (AGW) tissue samples using immunohistochemistry. The average number of IFN-α positive cells will be calculated from three high-power fields (400× magnification).
Change in Tissue IL-2 Expression in AGW Lesions (Measured by IHC)
Time frame: Baseline and Week 2
Quantification of IL-2 positive lymphocytes in AGW tissue samples using immunohistochemistry. Results are expressed as the mean number of positive cells across three high-power fields
Percentage Reduction in AGW Lesion Volume
Time frame: Baseline to Week 6
Lesion volume reduction calculated using the formula: [(Baseline Volume - Volume at Week 6) / Baseline Volume] × 100%. Therapeutic response will be classified as: No response: 0% reduction Minimal response: <50% reduction Partial response: 50-99% reduction Complete response: 100% reduction
Change in Serum IFN-α Levels (Measured by ELISA)
Time frame: Baseline and Week 6
Concentration of IFN-α in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
Change in Serum IL-2 Levels (Measured by ELISA)
Time frame: Baseline and Week 6
Concentration of IL-2 in serum samples measured using a quantitative sandwich ELISA. Results will be reported in pg/mL.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2025.
- Individual participant dataSharing planned: No
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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 Phase 2 study testing protein purified derivative in people with Human Papilloma Virus and Infections, run by Universitas Padjadjaran at 1 site in Indonesia.
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 3 inclusion and 7 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: finished, as of the sponsor's last update on 18 Jul 2025. 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 Indonesia. 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Change in Tissue IFN-α Expression in AGW Lesions (Measured by IHC) (time frame: Baseline and Week 2). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 18 Jul 2025.