Flat WartPhase 3NCT04290572
Efficacy and Safety of Oral Isotretinoin for the Treatment of Facial Recalcitrant Flat Warts
A Phase 3 study testing Isotretinoin capsules in people with Flat Wart, run by Centro Dermatológico Dr. Ladislao de la Pascua at 1 site in Mexico.
Trial summary
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Flat Wart
- What is being tested?
- Isotretinoin capsules
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 162 participants
- Where
- 1 siteMexico
- Study dates
- 15 Mar 2020to 31 Dec 2023
- 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 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Clinical and histological diagnosis of facial flats warts
- More than 2 years with facial flat warts
- Without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate)
Who cannot join
- Have the following conditions:
- Hypercholesterolemia
- Hypertriglyceridemia
- Liver disease
- Renal disease
- Sjögren syndrome
Show all 11Show fewer
- Pregnancy
- Lactation
- Depressive disorder
- Body mass index less than 18 points or higher than 25 points
- Contraindications for hormonal contraception or intrauterine device.
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Centro Dermatológico "Dr. Ladislao de la Pascua"
Mexico City, 06780
About this study
Official title: Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico "Dr. Ladislao de la Pascua": Randomized Double-blinded Clinical Trial of Three Arms
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Read the detailed description
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.
- Conditions
- Flat Wart
- Being tested
- Isotretinoin capsules
- Keywords
- flat wart, isotretinoin, facial warts
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin capsulesDrug
Also called Oral retinoid
Jelly capsules of isotretinoin
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin 10 mg/day | Experimental | One capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks. Receives: Drug: Isotretinoin capsules |
| Isotretinoin 20 mg/day | Experimental | One capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks. Receives: Drug: Isotretinoin capsules |
| Isotretinoin 30 mg/day | Active comparator | One capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. Receives: Drug: Isotretinoin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Complete clearance
Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Measured: 12 weeks
Incidence of serious adverse events
Proportion of participants that developed a serious side effect in the three arms during the clinical trial.
Measured: 12 weeks
Secondary outcomes (2)
Quality of life index
Difference in the Dermatology Life Quality Index score at the end of the study, comparing with the basal score. The minimum score is 0 points and the maximum 30 points. A score higher than 10 points means that the patient's life is severely affected by melasma.
Measured: 12 weeks
Adherence to intervention
Percentage of taken-doses of oral isotretinoin during the 12 weeks of the study.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2020
- Study start15 Mar 2020 (estimated)
- Primary completion28 Feb 2023 (estimated)
- Study completion31 Dec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Flat WartStudies 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
- Parallel groups
- Model description
- Randomized clinical trial of three-arms
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 162 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la Pascua
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- María Guadalupe Olguín-García, M.D.,MSc., Principal investigator, Centro Dermatológico Dr. Ladislao de la Pascua
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04290572
- Sponsor's protocol ID
- 176/2019
- Status last verified
- Feb 2020
- First submitted
- 27 Feb 2020
- Last updated
- 3 Mar 2020
- 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 3 Mar 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Oral Isotretinoin 10 mg, 20 mg and 30 mg for the Treatment of Facial Recalcitrant Flat Warts at Centro Dermatológico "Dr. Ladislao de la Pascua": Randomized Double-blinded Clinical Trial of Three Arms
- ClinicalTrials.gov ID
- NCT04290572
- Acronym / sponsor ID
- 176/2019
- Conditions
- Flat Wart
- Keywords
- flat wart, isotretinoin, facial warts
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 162 participants (estimated)
- Lead sponsor
- Centro Dermatológico Dr. Ladislao de la PascuaUniversity, hospital or other
- Study start
- 15 Mar 2020 (estimated)
- Primary completion
- 28 Feb 2023 (estimated)
- Study completion
- 31 Dec 2023 (estimated)
- First posted
- 2 Mar 2020 (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.
Randomized clinical trial to compare the efficacy of different doses of oral isotretinoin 10 mg/day, 20 mg/day and 30 mg/day during 12 weeks for the treatment of facial recalcitrant flat warts. The primary endpoint will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Detailed description
The investigators will recruit 162 participants with facial recalcitrant flat warts and randomize to the following three arms of intervention: Arm 1: nne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks; Arm 2: one capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks; and Arm 3: one capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. The primary endpoints will be the proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial; and the incidence of side effects related to oral isotretinoin treatment among the 3 arms of treatment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 3
- Model description
- Randomized clinical trial of three-arms
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin 10 mg/day | Experimental | Drug: Isotretinoin capsulesOne capsule of isotretinoin 10 mg plus one capsule of placebo, per day during 12 weeks. |
| Isotretinoin 20 mg/day | Experimental | Drug: Isotretinoin capsulesOne capsule of isotretinoin 20 mg plus one capsule of placebo, per day during 12 weeks. |
| Isotretinoin 30 mg/day | Active comparator | Drug: Isotretinoin capsulesOne capsule of isotretinoin 10 mg plus one capsule of isotretinoin 20 mg, per day during 12 weeks. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Clinical and histological diagnosis of facial flats warts
- More than 2 years with facial flat warts
- Without response to 2 or more topical interventions (tretinoin, imiquimod, cryosurgery and 5-fluorouracil) or oral interventions (cimetidine or zinc sulfate)
Key exclusion criteria (11 listed)
- Have the following 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 |
|---|---|---|
| Isotretinoin capsulesAlso: Oral retinoidJelly capsules of isotretinoin | Drug | Isotretinoin 10 mg/day, Isotretinoin 20 mg/day, Isotretinoin 30 mg/day |
Primary outcome
Complete clearance
Time frame: 12 weeks
Proportion of participants with total remission of facial flat warts at the end of the intervention in the three arms of the clinical trial.
Incidence of serious adverse events
Time frame: 12 weeks
Proportion of participants that developed a serious side effect in the three arms during the clinical trial.
2 secondary outcomes
Quality of life index
Time frame: 12 weeks
Adherence to intervention
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2020.
- 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.
María Guadalupe Olguín-García, M.D.,MSc. principal investigator
Centro Dermatológico Dr. Ladislao de la Pascua
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 Isotretinoin capsules in people with Flat Wart, run by Centro Dermatológico Dr. Ladislao de la Pascua at 1 site in Mexico.
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 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 Mar 2020. 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 Mexico. 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?
Contact María Guadalupe Olguín-García, M.D., MSc. (55387033 ext. 312, olguingog@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Complete clearance (time frame: 12 weeks). The study lists 2 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 3 Mar 2020.