Acne VulgarisPhase 4NCT07639073
Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris
A Phase 4 study testing Isotretinoin in people with Acne Vulgaris, run by Pakistan Institute of Medical Sciences at 1 site in Pakistan.
Trial summary
Background and Purpose: Acne vulgaris is a common skin condition that can cause significant physical and emotional distress. Oral isotretinoin is a highly effective treatment for severe or persistent acne. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Acne Vulgaris
- What is being tested?
- Isotretinoin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 sitePakistan
- Study dates
- Jul 2026to Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Both genders
- Age 18-45 years
- Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.
Who cannot join
- Patients who are pregnant or lactating
- Patients with history of endocrine disorders such as PCOS etc. or having drug induced acne
- Patients on corticosteroid treatment
- Patients who have hypersensitivity to the isotretinoin
- Patients who are taking any acne treatment
- Patients with hyperlipidemia, chronic renal failure or liver failure
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Pakistan1 site
Pakistan Institute of Medical Sciences(PIMS)
Islamabad
Dr Nareeman Ur Rehman, MBBS,FCPS, +923169560013, naree.khan1@gmail.com
About this study
Official title: Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris
Background and Purpose:
Acne vulgaris is a common skin condition that can cause significant physical and emotional distress. Oral isotretinoin is a highly effective treatment for severe or persistent acne. While the standard (conventional) dose is effective, it is often associated with side effects like dry skin, chapped lips, and altered labs.
Read more
The purpose of this study is to compare a lower daily dose of oral isotretinoin against the conventional daily dose in individuals with acne vulgaris.
What the Study Aims to Find Out:
Researchers want to determine if a low-dose regimen can match the effectiveness (efficacy) of the conventional dose while reducing the frequency and severity of side effects (safety).
Study Design:
Participants will be randomly assigned to receive either the low-dose oral isotretinoin or the conventional-dose oral isotretinoin. Researchers will monitor and compare acne clearance rates, patient satisfaction, and any side effects experienced by the participants throughout the treatment period.
Read the detailed description
This is a randomized, comparative clinical study designed to evaluate and compare the therapeutic efficacy and safety profile of two different dosing regimens of oral isotretinoin in patients diagnosed with acne vulgaris.
Eligible participants will be allocated into one of two treatment arms:
- Experimental Arm (Low Dose): Participants will receive a low daily dose of oral isotretinoin.
- Active Comparator Arm (Conventional Dose): Participants will receive the standard conventional daily dose of oral isotretinoin based on standard weight-based guidelines.
Primary Outcome:
Efficacy: Assessed by the percentage reduction in inflammatory and non-inflammatory acne lesions from baseline, as well as The Global Acne grading System(GAGS) Safety and Tolerability: Evaluated through the frequency, type, and severity of clinical adverse effects (e.g., cheilitis, xerosis) and periodic laboratory monitoring (including lipid profiles and liver function tests).
Follow-up visits will be conducted at regular intervals to monitor clinical response, manage side effects, and ensure patient compliance.
- Conditions
- Acne Vulgaris
- Being tested
- Isotretinoin
- Keywords
- Isotretinoin, Accutane, Acne Treatment, Dermatology, Low dose Isotretinoin, Conventional Dose Isotretinoin, Retinoids
- 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
Also called Accutane, Roaccutane
Oral isotretinoin capsules administered daily to participants for the treatment of acne vulgaris. This study evaluates two distinct dosing regimens to compare their relative efficacy and safety: 1) Low-Dose Regimen: Participants receive a reduced daily dose (e.g. 0.25 mg/kg/day). 2) Conventional-Dose Regimen: Participants receive the standard weight-based dose (e.g., 0.5 mg/kg/day). Treatment duration, monitoring schedules, and dose adjustments follow protocol specifications.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose Oral Isotretinoin | Experimental | Participants in this arm will receive a low-dose regimen of oral isotretinoin (e.g., 0.25mg/kg/day for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris. Receives: Drug: Isotretinoin |
| Conventional Dose Oral Isotretinoin | Active comparator | participants in this arm will receive conventional dose of oral isotretinoin (e.g. 0.5 mg/kg/day) for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris. Receives: Drug: Isotretinoin |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in Global Acne Grading System(GAGS)Scoring
The GAGS is a validated scoring system that calculates acne severity across six specific facial and torso areas (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each area is assigned a factor based on size, and lesions are graded from 0 (no lesions) to 4 (cystic lesions). The total score ranges from 0 to 44, where 0 is clear and higher scores indicate greater severity. Efficacy will be compared between the low-dose and conventional-dose arms based on the mean reduction in total GAGS score from baseline.
Measured: 12 weeks
Percentage change in total acne lesion count from baseline
The total lesion count is calculated by adding the number of inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones) on the face according to GAGS. Efficacy will be compared between the low-dose and conventional-dose arms based on the percentage reduction from day 0.
Measured: 12 weeks
Secondary outcomes (1)
Incidence and severity of treatment-emergent adverse events (TEAEs)
Frequency and severity of clinical side effects (such as cheilitis, xerosis/dry skin, conjunctivitis) and laboratory abnormalities (such as elevated liver enzymes or lipid profiles) will be evaluated and compared between the two dosing groups.
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 posted10 Jun 2026
- Study startJul 2026 (estimated)
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pakistan Institute of Medical Sciences
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Nareeman Ur Rehman, Pakistan Institute of Medical Sciences
- Investigators
- Dr Nareeman Ur Rehman, MBBS, FCPS, Principal investigator, Pakistan Institute of Medical Sciences (PIMS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07639073
- Sponsor's protocol ID
- PIMS-DERM-ISO-2026-01
- Status last verified
- Jun 2026
- First submitted
- 5 Jun 2026
- Last updated
- 10 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual participant data underlying the principal results of this study (including demographic data, baseline characteristics, efficacy outcomes, and safety parameters) will be made available to ensure transparency and validate study findings.
Study at a glance
From the registry record, last updated by the sponsor on 10 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparing the Efficacy and Safety of Low-Dose Oral Isotretinoin Versus Conventional-Dose in the Treatment of Acne Vulgaris
- ClinicalTrials.gov ID
- NCT07639073
- Acronym / sponsor ID
- PIMS-DERM-ISO-2026-01
- Conditions
- Acne Vulgaris
- Keywords
- Isotretinoin, Accutane, Acne Treatment, Dermatology, Low dose Isotretinoin, Conventional Dose Isotretinoin, Retinoids
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Pakistan Institute of Medical SciencesOther government
- Study start
- Jul 2026 (estimated)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 10 Jun 2026 (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.
Background and Purpose:
Acne vulgaris is a common skin condition that can cause significant physical and emotional distress. Oral isotretinoin is a highly effective treatment for severe or persistent acne. While the standard (conventional) dose is effective, it is often associated with side effects like dry skin, chapped lips, and altered labs.
The purpose of this study is to compare a lower daily dose of oral isotretinoin against the conventional daily dose in individuals with acne vulgaris.
What the Study Aims to Find Out:
Researchers want to determine if a low-dose regimen can match the effectiveness (efficacy) of the conventional dose while reducing the frequency and severity of side effects (safety).
Study Design:
Participants will be randomly assigned to receive either the low-dose oral isotretinoin or the conventional-dose oral isotretinoin. Researchers will monitor and compare acne clearance rates, patient satisfaction, and any side effects experienced by the participants throughout the treatment period.
Detailed description
This is a randomized, comparative clinical study designed to evaluate and compare the therapeutic efficacy and safety profile of two different dosing regimens of oral isotretinoin in patients diagnosed with acne vulgaris.
Eligible participants will be allocated into one of two treatment arms:
- Experimental Arm (Low Dose): Participants will receive a low daily dose of oral isotretinoin.
- Active Comparator Arm (Conventional Dose): Participants will receive the standard conventional daily dose of oral isotretinoin based on standard weight-based guidelines.
Primary Outcome:
Efficacy: Assessed by the percentage reduction in inflammatory and non-inflammatory acne lesions from baseline, as well as The Global Acne grading System(GAGS) Safety and Tolerability: Evaluated through the frequency, type, and severity of clinical adverse effects (e.g., cheilitis, xerosis) and periodic laboratory monitoring (including lipid profiles and liver function tests).
Follow-up visits will be conducted at regular intervals to monitor clinical response, manage side effects, and ensure patient compliance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose Oral Isotretinoin | Experimental | Drug: IsotretinoinParticipants in this arm will receive a low-dose regimen of oral isotretinoin (e.g., 0.25mg/kg/day for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris. |
| Conventional Dose Oral Isotretinoin | Active comparator | Drug: Isotretinoinparticipants in this arm will receive conventional dose of oral isotretinoin (e.g. 0.5 mg/kg/day) for the duration of the treatment period to evaluate its efficacy and safety in acne vulgaris. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Both genders
- Age 18-45 years
- Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.
Key exclusion criteria (6 listed)
- Patients who are pregnant or lactating
- Patients with history of endocrine disorders such as PCOS etc. or having drug induced acne
- Patients on corticosteroid treatment
- Patients who have hypersensitivity to the isotretinoin
- Patients who are taking any acne treatment
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 |
|---|---|---|
| IsotretinoinAlso: Accutane, RoaccutaneOral isotretinoin capsules administered daily to participants for the treatment of acne vulgaris. This study evaluates two distinct dosing regimens to compare their relative efficacy and safety: 1) Low-Dose Regimen: Participants receive a reduced daily dose (e.g. 0.25 mg/kg/day). 2) Conventional-Dose Regimen: Participants receive the standard weight-based dose (e.g., 0.5 mg/kg/day). Treatment duration, monitoring schedules, and dose adjustments follow protocol specifications. | Drug | Conventional Dose Oral Isotretinoin, Low Dose Oral Isotretinoin |
Primary outcome
Change from baseline in Global Acne Grading System(GAGS)Scoring
Time frame: 12 weeks
The GAGS is a validated scoring system that calculates acne severity across six specific facial and torso areas (forehead, right cheek, left cheek, nose, chin, and chest/upper back). Each area is assigned a factor based on size, and lesions are graded from 0 (no lesions) to 4 (cystic lesions). The total score ranges from 0 to 44, where 0 is clear and higher scores indicate greater severity. Efficacy will be compared between the low-dose and conventional-dose arms based on the mean reduction in total GAGS score from baseline.
Percentage change in total acne lesion count from baseline
Time frame: 12 weeks
The total lesion count is calculated by adding the number of inflammatory lesions (papules, pustules, nodules) and non-inflammatory lesions (open and closed comedones) on the face according to GAGS. Efficacy will be compared between the low-dose and conventional-dose arms based on the percentage reduction from day 0.
1 secondary outcome
Incidence and severity of treatment-emergent adverse events (TEAEs)
Time frame: 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Jun 2026.
- Related InfoLink provided by the sponsor.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual participant data underlying the principal results of this study (including demographic data, baseline characteristics, efficacy outcomes, and safety parameters) will be made available to ensure transparency and validate study findings.
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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.
Dr Nareeman Ur Rehman, MBBS, FCPS principal investigator
Pakistan Institute of Medical Sciences (PIMS)
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 Pakistan Institute of Medical Sciences at 1 site in Pakistan.
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 6 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: opening soon, as of the sponsor's last update on 10 Jun 2026. 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 Pakistan. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Dr Nareeman Ur Rehman, MBBS, FCPS (+923169560013, naree.khan1@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline in Global Acne Grading System(GAGS)Scoring (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 10 Jun 2026.