Evaluation of the efficacy, safety and tolerability of Tacrolimus ointment in Indian patients of moderate to severe atopic dermatitis: A multicentric, open label, phase III study

• Published in: Indian journal of dermatology, venereology, and leprology Vol. 69; no. 6
• Main Author: Saple DG, Torsekar RG, Pawanarkar V, Wali V, Ravichandran G, Dhanalakshmi UR, Dongre N, Ballary C, Desai A
• Format: Journal Article
• Language: English
• Published: Medknow Publications on behalf of The Indian Association of Dermatologists, Venereologists and Leprologists (IADVL) 03-05-2004
• Subjects: Tacrolimus, Safety, Efficacy, Atopic dermatitis
• ISSN: 0378-6323

AIM OF STUDY: Tacrolimus, a topical immunomodulator, has been
introduced as a new treatment for moderate to severe atopic dermatitis.
The present study was conducted to evaluate the efficacy, safety and
tolerability of Tacrolimus ointment in patients of atopic dermatitis in
an Indian setting. METHODS: The present study was a prospective, open,
multicentric, Phase III trial.The duration of study was 5 weeks,
including a 3-week active treatment period, preceded by a 1-week
washout phase and followed by a 1-week follow-up phase. Patients
diagnosed to be suffering from moderate to severe atopic dermatitis as
per the Rajka and Langeland criteria were treated with Tacrolimus
ointment 0.03% twice daily. Efficacy was assessed by modified Eczema
Area Sensitivity Index (mEASI) score, patient's and physician's global
assessment. Tolerability and safety was assessed by physical
examination, laboratory parameters and evaluation of adverse events.
RESULTS: There was a statistically significant decrease in the modified
Eczema Area Sensitivity Index (mEASI) score (P<0.05). Patient's and
Physician's global evaluation of treatment was complete resolution to
very good improvement in most of the patients. The laboratory values
were within normal limits. The drug was well tolerated. CONCLUSIONS:
This study confirms the efficacy and safety of Tacrolimus ointment
0.03% in Indian patients of moderate to severe atopic dermatitis.