Acne VulgarisPhase 3NCT06451237
Acne Remission Maintenance by Weekend Systemic Isotretinoin
A Phase 3 study testing Isotretinoin capsules in people with Acne Vulgaris, run by Alexandria University at 1 site in Egypt.
Trial summary
The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acne Vulgaris
- 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
- 60 participants
- Where
- 1 siteEgypt
- Study dates
- 20 Jan 2018to 20 Sep 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients (≥ 18 years) with moderate to severe facial acne, as per the Investigator Global Assessment (IGA) scale
Who cannot join
- patients on systemic acne medications in the past 3 months or topicals in the last month, pregnant or breastfeeding females, those with evidence of endocrine disturbances or using medications for comorbidities
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach
The goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.
Read the detailed description
Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin capsules
- Medical subject headings
- Acne Vulgaris
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Isotretinoin capsulesDrug
Also called Adapalene gel
A one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel.
| Study group | Role | What they receive |
|---|---|---|
| Adapalene group | Active comparator | Patients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel. Receives: Drug: Isotretinoin capsules |
| Full Iso group | Active comparator | Patients received full isotretinoin course for treatment, and maintained on weekend isotretinoin. Receives: Drug: Isotretinoin capsules |
| Clearance Iso | Active comparator | Patients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin. Receives: Drug: Isotretinoin capsules |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of acne relapse during maintenance phase
percent of patients having one grade worsening of their acne investigator global assessment scale achieved by end of treatment phase as assessed by the physician during follow up
Measured: one year
Timing of acne relapse after initiating maintenance
The time interval between initiating maintenance and the occurrence of one grade worsening of the patient's investigator global assessment scale achieved by the end of treatment phase as assessed by the physician during follow up
Measured: one year
Maximum severity of acne relapse during follow up
Maximum investigator global assessment score reached by the the patient during the follow up year
Measured: One year
Incidence of adverse effects
Percent of patients reporting adverse effects in general, percent of patients reporting each category of side effects, including disturbed lipid profile, raised transaminases, psychological changes, dryness, hair shedding, ...
Measured: One year
Secondary outcomes (2)
subjective patient satisfaction by maintenance regimen
A patient oriented outcome, in which the patients are asked by the end of maintenance year to report their degree of satisfaction by the efficacy of maintenance regimen to prevent acne relapse on a visual analogue scale of 1-10, in which 1 is lowest satisfaction and 10 is highest satisfaction.
Measured: one year
Subjective convenience of maintenance regimen to patient
A patient oriented outcome to assess the degree of convenience of the maintenance regimen for the patient as reported on a visual analogue scale of 1-10, where 1 is the lowest convenience, and 10 is the highest convenience.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Jun 2024
- Study start20 Jan 2018
- Primary completion20 Dec 2022
- Study completion20 Sep 2023
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.
- More trials run by Alexandria UniversityThe sponsor's other registered studies.
- 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
- Interventional study on 3 parallel groups, with random assignment and longitudinal follow up, conducted in two phases (treatment and maintenance).
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- Alexandria University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Carmen Ibrahim Farid, Alexandria University
- Investigators
- Carmen Farid, MD, Principal investigator, Professor of Dermatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06451237
- Sponsor's protocol ID
- 0107396
- Status last verified
- Jun 2024
- First submitted
- 1 May 2024
- Last updated
- 11 Jun 2024
- 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 11 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weekend Systemic Isotretinoin for Maintaining Acne Remission: A Novel Approach
- ClinicalTrials.gov ID
- NCT06451237
- Acronym / sponsor ID
- 0107396
- Conditions
- Acne Vulgaris
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- Alexandria UniversityUniversity, hospital or other
- Study start
- 20 Jan 2018 (actual)
- Primary completion
- 20 Dec 2022 (actual)
- Study completion
- 20 Sep 2023 (actual)
- First posted
- 11 Jun 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 goal of this study is to learn if isotretinoin oral tablets as a weekend regimen are safe and effective to maintain freedom from acne lesions in young adults who have completed a full course of isotretinoin on daily basis and achieved total control of the acne activity.
Detailed description
Three groups of adult acne patients will be given a full course of isotretinoin with a cumulative dose of 120-150 mg/Kg weight in the 1st two groups, and till lesional clearance in the 3rd group with an additional month of maintenance. Afterwards, the 1st group will use adapalene gel every other day for maintenance, the 2nd and 3rd groups will use weekend oral isotretinoin. Patients will be followed for a year for reappearance of acne lesions, and safety of maintenance regimens. Patients opinion will be also sought.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- Interventional study on 3 parallel groups, with random assignment and longitudinal follow up, conducted in two phases (treatment and maintenance).
| Arm | Type | Receives |
|---|---|---|
| Adapalene group | Active comparator | Drug: Isotretinoin capsulesPatients received full Isotretinoin course for treatment, and maintained on every other day adapalene gel. |
| Full Iso group | Active comparator | Drug: Isotretinoin capsulesPatients received full isotretinoin course for treatment, and maintained on weekend isotretinoin. |
| Clearance Iso | Active comparator | Drug: Isotretinoin capsulesPatients treated by systemic isotretinoin till full clearance and for a month thereafter, and maintained on weekend isotretinoin. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Adult patients (≥ 18 years) with moderate to severe facial acne, as per the Investigator Global Assessment (IGA) scale
Key exclusion criteria (1 listed)
- patients on systemic acne medications in the past 3 months or topicals in the last month, pregnant or breastfeeding females, those with evidence of endocrine disturbances or using medications for comorbidities
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: Adapalene gelA one year follow up for patients on three maintenance regimens after acne clearance, including weekend isotretinoin and adapalene gel. | Drug | Adapalene group, Clearance Iso, Full Iso group |
Primary outcome
Incidence of acne relapse during maintenance phase
Time frame: one year
percent of patients having one grade worsening of their acne investigator global assessment scale achieved by end of treatment phase as assessed by the physician during follow up
Timing of acne relapse after initiating maintenance
Time frame: one year
The time interval between initiating maintenance and the occurrence of one grade worsening of the patient's investigator global assessment scale achieved by the end of treatment phase as assessed by the physician during follow up
Maximum severity of acne relapse during follow up
Time frame: One year
Maximum investigator global assessment score reached by the the patient during the follow up year
Incidence of adverse effects
Time frame: One year
Percent of patients reporting adverse effects in general, percent of patients reporting each category of side effects, including disturbed lipid profile, raised transaminases, psychological changes, dryness, hair shedding, ...
2 secondary outcomes
subjective patient satisfaction by maintenance regimen
Time frame: one year
Subjective convenience of maintenance regimen to patient
Time frame: one year
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 11 Jun 2024.
- Individual participant dataSharing planned: No
Related trials for Acne Vulgaris
Active, not recruiting
Clinical Study to Evaluate the Safety and Efficacy of Candela Technology
Hair Reduction, Tattoo Removal
Not yet recruiting
Evaluating a Brightening Serum for Post-Inflammatory Hyperpigmentation
Post-inflammatory Hyperpigmentation, Post-acne Hyperpigmentation
RecruitingPhase 3
Phase 3 Study of Denifanstat in Participants With Moderate to Severe Acne (AURORA)
Acne Vulgaris
Enrolling by invitationPhase 2/3
A Split-Face Comparative Study of Mono Threads Versus Combination With Plasma Gel for the Treatment of Post-Acne Scars
Acne
RecruitingObservational study
Collection of Samples From Subjects With Various Skin Conditions and Healthy Volunteers
Acne, Atopic Dermatitis
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.
Carmen Farid, MD principal investigator
Professor of Dermatology
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 Acne Vulgaris, run by Alexandria University 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 1 inclusion and 1 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 11 Jun 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 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 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?
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?
Incidence of acne relapse during maintenance phase (time frame: one year). The study lists 4 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 11 Jun 2024.