Acne VulgarisPhase 4NCT05218486
Effect of Oral Isotretinoin on The Level of SerumYKL40 in Acne Vulgaris Patients
A Phase 4 study testing Isotretinoin in people with Acne Vulgaris, run by Alshimaa Abbas Mohamed Ebrahim at 1 site in Egypt.
Trial summary
The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients. Read more about this study
- Who is it for?
- Ages 15 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Aug 2021to 30 Sep 2022
- Phase
- Phase 4
- 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 15 to 60 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy persons of both sexes with moderate and severe acne.
- Age above 14 years.
Who cannot join
- Pregnant and lactating women, immunocompromised patients.
- History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.
- History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- Cases with known hypersensitivity reaction to isotretinoin.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
The aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Read the detailed description
Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum YKL-40 level in acne patient before and after oral isotretinoin treatment
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
IsotretinoinDrug
Isotretinoin is a vitamin-A derivative for treatment of moderate to severe acne used in a dose from 20-40 mg for 3 months duration
| Study group | Role | What they receive |
|---|---|---|
| Isotretinoin group | Active comparator | Patients will be treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum YKL40 will be assessed before and after treatment Receives: Drug: Isotretinoin |
| Control group | No intervention | Assessment of serum YKL40 in healthy individuals |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Assessment in serum level YKL40 level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum YKL40 and effect of isotretinoin therapy on it.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2022
- Study start1 Aug 2021
- Primary completion30 Sep 2022 (estimated)
- Study completion30 Sep 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acne VulgarisStudies 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Alshimaa Abbas Mohamed Ebrahim
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Alshimaa Abbas Mohamed Ebrahim, Aswan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05218486
- Sponsor's protocol ID
- 551/7/21
- Status last verified
- Sep 2022
- First submitted
- 5 Jan 2022
- Last updated
- 6 Sep 2022
- 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 6 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of The Effect of Oral Isotretinoin on The Level of Serum YKL40 in Acne Vulgaris Patients
- ClinicalTrials.gov ID
- NCT05218486
- Acronym / sponsor ID
- 551/7/21
- Conditions
- Acne Vulgaris
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Alshimaa Abbas Mohamed EbrahimUniversity, hospital or other
- Study start
- 1 Aug 2021 (actual)
- Primary completion
- 30 Sep 2022 (estimated)
- Study completion
- 30 Sep 2022 (estimated)
- First posted
- 1 Feb 2022 (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 aim of the study is to evaluate the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Detailed description
Acne vulgaris is a common chronic inflammatory disease of the skin. It is found in about 80% of young adults and adolescents. It is a disease that affects the pilosebaceous units of the skin and may result in inflammatory or non-inflammatory lesions,Oral isotretinoin (13-cis-retinoic acid) is the only drug that counteracts all the pathogenetic mechanisms that contribute to the development of acne .The standard dose of isotretinoin is 0.5 to 1 mg/kg per day for 4 months to a cumulative dose of 120-140 mg/kg is effective in the management of acne vulgaris The scope of our study is to detect serum YKL-40 level in acne patient before and after oral isotretinoin treatment
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Isotretinoin group | Active comparator | Drug: IsotretinoinPatients will be treated with Isotretinoin in a dose (from 20 to 40) for 3 months and serum YKL40 will be assessed before and after treatment |
| Control group | No intervention | –Assessment of serum YKL40 in healthy individuals |
Who may qualify
- Ages
- 15 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (2 listed)
- Healthy persons of both sexes with moderate and severe acne.
- Age above 14 years.
Key exclusion criteria (4 listed)
- Pregnant and lactating women, immunocompromised patients.
- History of chronic liver disease, hyperlipidemia, non-inflammatory acne conditions, , history of neurologic disorders, history of neoplastic disorders, and history of cardiac disease.
- History of systemic acne treatment for at least 4 weeks prior to inclusion and no topical treatments for at least 2 weeks.
- Cases with known hypersensitivity reaction to isotretinoin.
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 |
|---|---|---|
| IsotretinoinIsotretinoin is a vitamin-A derivative for treatment of moderate to severe acne used in a dose from 20-40 mg for 3 months duration | Drug | Isotretinoin group |
Primary outcome
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients.
Time frame: 3 months
Assessment in serum level YKL40 level in acne vulgaris patients after isotretinoin therapy with assesment of its level before starting therapy for detecting changes in serum YKL40 and effect of isotretinoin therapy on it.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Sep 2022.
- 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 4 study testing Isotretinoin in people with Acne Vulgaris, run by Alshimaa Abbas Mohamed Ebrahim at 1 site in Egypt.
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 2 inclusion and 4 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 6 Sep 2022. 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 Egypt. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
Evaluation of the effect of oral isotretinoin on SerumYKL40 in acne vulgaris patients. (time frame: 3 months). 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 6 Sep 2022.