| Acne
vulgaris is a persistent inflammatory skin disease that affects the hair
follicles, caused by excess sebum production, inflammation, and microbial
colonization. Clinically, pleomorphic lesions such as comedones, papules,
pustules, nodules, and cysts are indicative of this condition. Typically,
seborrheic regions such as the face, upper chest, and back of the trunk are
impacted. AIM: To
evaluate the clinical efficacy of conventional, intermittent, and low-dose
Isotretinoin regimens in acne vulgaris using the Global Acne Grading System
(GAGS).
OBJECTIVES:
• To compare the conventional, intermittent, and low-dose regimens of oral
Isotretinoin in terms of efficacy, side effects, and compliance. • To evaluate
the recurrence rates associated with Isotretinoin treatment regimens.
JUSTIFICATION
FOR STUDY
Balancing
Efficacy and Safety • Improving Patient Compliance: • Cost-Effectiveness:
Lower-dose regimens can be more affordable • Reducing Relapse Rates: Continuous
low-dose regimens have shown promise in maintaining long-term remission of acne
with fewer relapses compared to intermittent dosing schedules. • Such research
can lead to optimized acne management strategies that balance patient
satisfaction and cost, ultimately improving outcomes for individuals affected
by acne vulgaris.
Methodology:
Source of
data – Patients visiting the dermatology OP, CHRI
INCLUSION
CRITERIA: • Patients with failure of first-line therapy.
• Moderate
to severe acne frequently relapsing
• Moderate
acne with imminent scarring
• Severe
acne with nodules and cysts
•
Inflammatory acne with scarring
• Patients
who are married and not planning for pregnancy are advised to use
contraceptives.
EXCLUSION
CRITERIA:
• Age less
than 18 years
• Pregnancy, married females planning for
pregnancy.
•
Drug-induced acne.
• Abnormal
liver functional tests, h/o Hyperlipidemia.
•
Musculoskeletal deformity
· Patients who fulfil the inclusion
criteria will be allocated to the study.
· • An informed consent letter will be
obtained from the patient in their regional language after explaining the study
in detail to them. Before starting Isotretinoin therapy, it is important to
perform fasting lipid profile, Liver function tests, complete blood picture,
blood glucose, and creatinine phosphokinase, Renal function test and ESR.
Additionally, screening for cutaneous and ocular changes is necessary.
Monitoring of lipid profile, Liver function tests, and kidney function tests
should be done every 2 weeks for the first month and then once in a month.
• The
patients will be divided into three groups for comparison of the efficacy of
Isotretinoin.
72 patients
will be randomized by random number generator app into 3 different groups of 24
each.
• Group C: Conventional dose of Isotretinoin
will be administered as a dose of 0.5 mg/kg/day
• Group I:
Intermittent dose of Isotretinoin will be administered as 0.5 mg/kg/day on
alternate days.
• Group L: A
Low dose of Isotretinoin will be administered as 0.2 mg/kg/day.
• All the
groups will be given topical Clindamycin as a standard of care treatment.
• Withdrawal criteria from trial – • Patients
who will not respond to a low dose of isotretinoin for 1 month will be shifted
to the intermittent and Conventional group.
• A patient
who will accidentally get pregnant needs to be immediately withdrawn from the
trial.
. • Ultimately, it will be determined which
group of patients will recover from lesions faster.
Study
procedure:
The acne
severity is evaluated with the Global Acne Grading System.
• This
grading system quantifies lesions such as comedones, papules, pustules, and
nodules, on various anatomical regions like the forehead, right cheek, left
cheek, nose, chin, chest, and back. Each kind of lesion is assigned a grade
based on its severity. • Additionally, each zone is assigned a factor ranging
from 1 to 3, depending on its location.
• Location Factor Forehead 2 Right cheek 2
Left cheek 2 Nose 1 Chin 1 Chest and upper back 3 The score is derived by
adding up the local scores across all zones.
• Global Acne Grading System score is the sum
of local scores, and acne severity was graded as :- 1-18-Mild 19-30- Moderate
31-38- Severe >39-VerySevere
Expected
duration of the subject participation: 2
months
Benefits
of the Study (for participants and others):
1.
Effective
Treatment: Access to isotretinoin, a proven medicine for moderate to
severe acne.
2.
Lower
Side Effects: Low-dose or intermittent treatment may work well with fewer
problems like dryness.
3.
Regular
Check-ups: Participants will be closely monitored, so any side effects
can be managed early.
Possible
Risks:
- Most common: dry lips (in about
90% of users).
- Other common: sun sensitivity,
dry mouth, dry skin.
- Blood changes: raised
triglycerides or ESR.
Confidentiality:
- Personal details will be kept
private.
- Names will not appear in
publications.
Treatment
for Complications:
- No major risks expected.
- If any problem occurs, free
treatment will be given at the hospital.
Voluntary
Participation:
Requirement
of blood samples: Yes, blood samples are required for blood investigations.
Costs and source of investigations and drugs: He/She will not be charged for
consultation. All the investigations will be done free of the cost.
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