Effect of tacrolimus ointment vs white soft petroleum jelly in treatment of drug induced lip dryness.

Comparative Study Between Tacrolimus 0.1% Ointment Versus Topical White Soft Petrolatum Jelly In The Treatment Of Oral Retinoids Induced Cheilits

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2022/01/039574

Enrollment

Registered

2022-01-19

Start date

Unknown

Completion date

Unknown

Last updated

2022-02-21

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

Conditions

Health Condition 1: K130- Diseases of lips

Interventions

Intervention1: Tacrolimus 0.1% ointment: Applied as thin layer to affects area twice a week for 90 days. Control Intervention1: White soft petrolatum: Applied as thin layer to all affected areas twice

Eligibility

Inclusion criteria

Inclusion criteria: Patients of both sexes with age range of 18-60 years, taking oral isotretinoin or acitretin.

Exclusion criteria

Exclusion criteria: Patients with past history of cheilitis, pregnant or lactating females and those having immunosuppression due to any disease/drug were excluded from the study.

Design outcomes

Primary

Measure	Time frame
Change from baseline in cheilitis based on ICGS (Isotretinoin Cheilitis Grading Scale)Timepoint: Day 0, day3, day 7, day 14, day 28, day 60, day 90	—

Secondary

Measure	Time frame
1.Time required for resolution of cheilitis using topical tacrolimus 0.1% ointment (Group A) Timepoint: Day 0, day3, day 7, day 14, day 28, day 60, day 90;2.Time required for resolution of cheilitis using white soft petrolatum jelly (Group B)Timepoint: Day 0, day3, day 7, day 14, day 28, day 60, day 90	—

Countries

India

Contacts

Public ContactRohit Kothari

Dr D Y Patil Medical College and Hospital, Pimpri

ajaikmathur@gmail.com9468085015

Outcome results

None listed

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