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Comparative study of oral spironolactone versus oral isotretinoin in treatment of acne in post-adolescent female patients.

Comparative study of efficacy and safety of oral spironolactone versus oral isotretinoin in female patients with post-adolescent acne. - NIL

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2025/09/094187
Enrollment
40
Registered
2025-09-03
Start date
Unknown
Completion date
Unknown
Last updated
2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: L700- Acne vulgaris

Interventions

Intervention1: TABLET ISOTRETINOIN: Dose:0.5mg/kg Frequency: once a day Route of administration: Oral Total duration: 3 months Control Intervention1: TABLET SPIRONOLACTONE: Dose:100mg Frequency: once

Sponsors

Dr Shivani Tripathi
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: (1)All women of 25-45 years of age with acne of grade 2 and 3 (as per Pillsbury scale). (2)Women with facial acne involving lower third of face (mandibular line, perioral region, and side of the neck). (3)Cases willing to give informed consent.

Exclusion criteria

Exclusion criteria: (1)Patients below the age of 25 years. (2)Patients with grade 1 and 4 (as per Pillsbury scale) (3)Patients with predominately truncal acne. (4)Patients who have been on any topical or systemic treatment in last 1 month. (5)Patient who have undergone procedures such as any chemical peel, acne scar surgery in last 15 days prior to enrollment. (6)Pregnant and lactating women. (7)Patients planning to conceive. (8)Females on contraceptive or other medication that cause or worsen acne. (9)Patients on corticosteroids/antiepileptics/AKT/ART/antipsychotics. (10)Patient suffering from acne rosacea and other bacterial infections on face confounding the diagnosis of acne vulgaris. (11)Patient suffering from Androgen-secreting adrenal or ovarian tumour, Cushing?s syndrome, Congenital adrenal hyperplasia. (12)Patients who are immune-compromised or taking immunosuppressant. (13)Patients undergoing chemotherapy. (14)Patients with poor general health.

Design outcomes

Primary

MeasureTime frame
Pillsbury grading scale, CADI, side effectsTimepoint: baseline, 2 week, 1 month, 2 month, 3 month

Secondary

MeasureTime frame
investigations: CBC, LFT, RFT, Hormonal profile, ultrasonography abdominal and pelvis, serum TSH, serum magnesiumTimepoint: baseline

Countries

India

Contacts

Public ContactDr Shivani Tripathi

SBKS MI & RC

drkishanninama.dermatologist@gmail.com9099025287

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026