Enlarged PoresPhase 3NCT06293755
Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores
A Phase 3 study testing Microneedle patch and Intradermal injection in people with Enlarged Pores, run by Dhurakij Pundit University at 1 site in Thailand.
Trial summary
The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Enlarged Pores
- What is being tested?
- Microneedle patch and Intradermal injection
- Type of treatment
- Injection or infusion, Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 siteThailand
- Study dates
- 28 Feb 2024to 25 Jun 2024
- Phase
- Phase 3
- 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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- At least 18 years old and concerned about enlarged pores
- Have pore size 0.3-0.6 mm
- Have pore parameter in each other side of faces not different more than 5%
Who cannot join
- Any neuromuscular condition
- Pregnancy or breast feeding
- History of allergy : Botulinum toxin, topical anesthesia
- History of keloid or hypertrophic scar
- History of coagulation or receiving medication that causes coagulation disorder
- Using drugs that have interaction with Botulinum toxin
Show all 9Show fewer
- Using topical medication that improves enlarged pores in 1 month
- Taking medication that improves enlarged pores in 1 month
- Receiving the laser/treatment/chemical peeling in 6 months
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin
The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.
- Conditions
- Enlarged Pores
- Being tested
- Microneedle patch, Intradermal injection
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Microneedle patchDevice
with 20 units botulinum toxin
Intradermal injectionDevice
with 20 units botulinum toxin
| Study group | Role | What they receive |
|---|---|---|
| Microneedle patch with Botulinum toxin | Experimental | Participants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side. Receives: Device: Microneedle patch |
| Intradermal Botulinum toxin injection | Active comparator | Participants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side. Receives: Device: Intradermal injection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
the used pore scores, patients with visible pores took the score "1," and those with enlarged pores took "2." When black heads were embedded on facial pores the score was "3." The scores were assessed by 2 investigators who were blinded to the treatment used on each side.
Measured: Post-intervention, week 4 and week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Mar 2024
- Study start28 Feb 2024
- Primary completion5 Mar 2024 (estimated)
- Study completion25 Jun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Enlarged PoresStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 16 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Dhurakij Pundit University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chotip Jitudomtham, Dhurakij Pundit University
- Investigators
- Chotip Jitudomtham, MD, Principal investigator, Dhurakij Pundit University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06293755
- Sponsor's protocol ID
- COA022/66
- Status last verified
- Feb 2024
- First submitted
- 28 Feb 2024
- Last updated
- 5 Mar 2024
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Salem RM, Salah SAE, Ibrahim SE. Microbotox injection versus its topical application following microneedling in the treatment of wide facial pores: A split face comparative study. J Cosmet Dermatol. 2023 Apr;22(4):1249-1255. doi: 10.1111/jocd.15590. Epub 2023 Jan 6.
PubMed 36606384
Study at a glance
From the registry record, last updated by the sponsor on 5 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of Microneedle Patch With Botulinum Toxin in Management of Enlarged Facial Pores Compared to Intradermal Botulinum Toxin
- ClinicalTrials.gov ID
- NCT06293755
- Acronym / sponsor ID
- COA022/66
- Conditions
- Enlarged Pores
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 16 participants (estimated)
- Lead sponsor
- Dhurakij Pundit UniversityUniversity, hospital or other
- Study start
- 28 Feb 2024 (actual)
- Primary completion
- 5 Mar 2024 (estimated)
- Study completion
- 25 Jun 2024 (estimated)
- First posted
- 5 Mar 2024 (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.
The purpose of this study is to assess the efficacy and safety of microneedle patch with botulinum toxin for improving enlarged pores.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Microneedle patch with Botulinum toxin | Experimental | Device: Microneedle patchParticipants recieve microneedle path with 20 units Botulinum toxin at nose and cheek one side. |
| Intradermal Botulinum toxin injection | Active comparator | Device: Intradermal injectionParticipants recieve intradermal 20 units Botulinum toxin injection at nose and cheek in other side. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- At least 18 years old and concerned about enlarged pores
- Have pore size 0.3-0.6 mm
- Have pore parameter in each other side of faces not different more than 5%
Key exclusion criteria (9 listed)
- Any neuromuscular condition
- Pregnancy or breast feeding
- History of allergy : Botulinum toxin, topical anesthesia
- History of keloid or hypertrophic scar
- History of coagulation or receiving medication that causes coagulation disorder
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 |
|---|---|---|
| Microneedle patchwith 20 units botulinum toxin | Device | Microneedle patch with Botulinum toxin |
| Intradermal injectionwith 20 units botulinum toxin | Device | Intradermal Botulinum toxin injection |
Primary outcome
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score
Time frame: Post-intervention, week 4 and week 16
the used pore scores, patients with visible pores took the score "1," and those with enlarged pores took "2." When black heads were embedded on facial pores the score was "3." The scores were assessed by 2 investigators who were blinded to the treatment used on each side.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Mar 2024.
- Results publication: PubMed 36606384Salem RM, Salah SAE, Ibrahim SE. Microbotox injection versus its topical application following microneedling in the treatment of wide facial pores: A split face comparative study. J Cosmet Dermatol. 2023 Apr;22(4):1249-1255. doi: 10.1111/jocd.15590. Epub 2023 Jan 6.
- Individual participant dataSharing planned: No
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.
Chotip Jitudomtham, MD principal investigator
Dhurakij Pundit University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Microneedle patch and Intradermal injection in people with Enlarged Pores, run by Dhurakij Pundit University at 1 site in Thailand.
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 9 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 5 Mar 2024. 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 Thailand. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change from baseline of enlarged pores as measured by VISIA (pores parameter) and using pore score (time frame: Post-intervention, week 4 and week 16). 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 NCT06293755, which also lists 1 linked publication.
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 5 Mar 2024.