Low-Dose Versus Conventional-Dose Oral Isotretinoin for Acne Vulgaris
ConditionAcne Vulgaris
Trial statusNot yet recruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18-45
SponsorPakistan Institute of Medical Sciences
About this trial
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.
Eligibility criteria
Qualifiers
Both genders
Age 18-45 years
Patients who are clinically diagnosed with moderate to severe acne vulgaris as per criteria defined in operational definition.
Disqualifiers
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
Trial design
Treatments tested in this trial
- Isotretinoin
Treatment groups
164 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov