A study comparing once daily versus an itch based multiple times Ddaily application of a superpotent steroid cream in lichen simplex chronicus

Phase 2/3

Not yet recruiting

Conditions: Lichen simplex chronicus,

Registration Number: CTRI/2022/10/046885

Lead Sponsor: All India Institute of Medical Sciences

Brief Summary: Lichen simplex chronicus is a chronic pruritic condition characterised by areas of thickened skin caused by habitual itching, scratching and rubbing of the skin. The standard prescription consists of topical corticosteroids applied once or twice daily but response is usually slow and partial. However in clinical practice it was found that itch-based multiple times application of high potency topical steroids led to reduction in total duration of treatment and thus the total cumulative dose. An itch-based application breaks the itch-scratch cycle and also leads to habit reversal and thus resulting in much better clinical outcome.

Detailed Description: Not available

Recruitment & Eligibility

Status: Not Yet Recruiting

Sex: All

Target Recruitment: 50

Inclusion Criteria

1.Patients with clinical diagnosis of lichen simplex chronicus 2.More than 18 years of age 3.Patients with well circumscribed lesions of lichen simplex chronicus.

Exclusion Criteria

1.Use of systemic medications for treatment of other diseases which may act on the lesion 2.Lichen simplex chronicus due to underlying systemic or dermatological diseases 3.Lichen simplex chronicus superimposed on any other skin lesions 4.Lichen simplex chronicus of the anogenital region 5.Patients who do not consent for study or follow up 6.Pregnant and lactating females.

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Change in the grade of lichenification of the lesion and change in 5 D pruritus score	At the end of 16 weeks

Secondary Outcome Measures

Name	Time	Method
To assess the change in ItchyQol in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.	At the end of 16 weeks
To assess the change in VAS in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.	At the end of 16 weeks
To assess the change in area of lesion in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.	At the end of 16 weeks
To assess the side effects of topical corticosteroids in patients with lichen simplex chronicus who are applying clobetasol propionate cream 0.05% once daily versus itch-based multiple times daily application.	At the end of 16 weeks

Trial Locations

Locations (1): All India Institute of Medical Sciences
🇮🇳
Delhi, DELHI, India
All India Institute of Medical Sciences
🇮🇳Delhi, DELHI, India
Sree Parvathy V
Principal investigator
9446042368
sreeparvathy.sh@gmail.com