| CTRI Number |
CTRI/2016/11/007511 [Registered on: 30/11/2016] Trial Registered Retrospectively |
| Last Modified On: |
30/11/2016 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Assessment of Steroneo Skin Cream (Physalis Angulata Supercritical Extract) application for treatment of eczematous lesions |
|
Scientific Title of Study
|
Assessment of Efficacy, Tolerability and Safety of Steroneo Skin Cream (Physalis Angulata Supercritical Extract) application for treatment of eczematous lesions: A Prospective, Open-label, Non-Comparative Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| CHSPL/CRL/01-2016 |
Protocol Number |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Rashid Shaikh |
| Designation |
Dermatologist, Cosmetologist, Hair Specialist |
| Affiliation |
Rehmat Clinic |
| Address |
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Thane
MAHARASHTRA
400601
India |
| Phone |
9820366255 |
| Fax |
|
| Email |
dr.rashidshaikh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Rashid Shaikh |
| Designation |
Dermatologist, Cosmetologist, Hair Specialist |
| Affiliation |
Rehmat Clinic |
| Address |
Dr.Rashid Shaikh
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Dr.Rashid Shaikh
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Thane
MAHARASHTRA
400601
India |
| Phone |
9820366255 |
| Fax |
|
| Email |
dr.rashidshaikh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Rashid Shaikh |
| Designation |
Dermatologist, Cosmetologist, Hair Specialist |
| Affiliation |
Rehmat Clinic |
| Address |
Dr.Rashid Shaikh
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Dr.Rashid Shaikh
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Thane
MAHARASHTRA
400601
India |
| Phone |
9820366255 |
| Fax |
|
| Email |
dr.rashidshaikh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Cheryl Laboratories Pvt. Ltd., Thane, Maharashtra |
|
|
Primary Sponsor
|
| Name |
Rehmat Clinic |
| Address |
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa,
Thane (W) 400 601
Maharashtra, India |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Rashid Shaikh |
Rehmat Clinic |
Dr.Rashid Shaikh
Dermatologist, Cosmetologist, Hair Specialist,
Ground Floor, Rehmat Manzil
Nr. TJSB, 62 K-Villa, Thane (W)
Thane
MAHARASHTRA |
9820366255
9820366255
dr.rashidshaikh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Suraksa - Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Eczema of skin, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Steroneo Skin Cream |
30gm of Physalis Angulata Supercritical Extract used topically twice a day |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Clinically diagnosed with eczematous lesions of any of the following types and requiring mild to moderate topical steroid therapy:
• Atopic dermatitis
• Contact dermatitis
• Xerotic eczema
• Nodular eczema
• Seborrheic dermatitis
• Neurocutaneous dermatitis (lichen simplex chronicus)
• Drug eruptions, photo-dermatitis
• Pruritus requiring topical corticosteroids
Patients/parents who sign the written informed consent form
Patients willing to and able to understand and comply with all study requirements
|
|
| ExclusionCriteria |
| Details |
1. Patients having any of the following conditions:
• Lichen planus
• Severe dermatitis requiring systemic corticosteroids
• Infantile dermatitis
2. Patients requiring systemic corticosteroids on any form
3. Pregnant and lactating women
4. Patients with known hypersensitivity to any of the ingredients/excipients of the study cream
5. Any other condition, which in the opinion of the clinician/investigator, could interfere significantly with the treatment and assessment process
6. Use of any investigational therapy within 30 days prior to randomization
7. Patients not willing to provide written informed consent
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To assess the efficacy of Steroneo Physalis Angulata Supercritical Extract application for treatment of eczematous lesions. |
12 weeks. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Dermatology Life Quality Index would be assessed using a 10 item questionnaire by patients above 16 years of age
Reduction in number and size of lesions of eczema.
Appearance of new lesions of eczema.
Pruritus Score will be assessed on a scale of 0 to 3.
Erythema will be assessed on a scale of 0 to 3.
Global assessment of response to therapy evaluated by the doctors on a 5point scale.
Global assessment of tolerability to therapy would be assessed by the patients on a 5point scale.
|
12 weeks |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Post Marketing Surveillance |
|
Date of First Enrollment (India)
|
06/09/2016 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Dermatitis or eczema, is an inflammatory reaction of skin characterized by itchy, erythematous, vesicular, weeping, and crusting patches.(2) It is also commonly used to describe atopic dermatitis (AD) or atopic eczema.Global prevalence of eczema is about 3.5% with over 230 million people affected in 2010 (3.5% of the population).The lifetime clinician-recorded prevalence of eczema has been seen to peak in infancy, with female predominance of eczema presentations occurring during the reproductive period of 15–49 years.
There is no known cure for eczema and the treatment aims at controlling symptoms by reducing inflammation and relieving itching. Moisturizing agents or emollients and topical steroids form the mainstay of management of eczema in most cases. Topical corticosteroids form the mainstay of treatment for many skin conditions. If used appropriately, they are safe and effective. However, on many occasions patients self-medicate thus increasing the risk of local adverse effects, poor clinical response and treatment failure. The most frequent adverse effects include atrophy, striae, rosacea, perioral dermatitis, acne, and purpura. Less frequent adverse effects include hypertrichosis, pigmentation alterations, delayed wound healing, and exacerbation of skin infections. Also, the steroids can cause effects such as immunosuppression, cell turn-over reduction, tissue atrophy, extracellular matrix degradation, drying and, as a consequence, premature and/or exacerbate aging which is a cause of concern.
Physalis Angulata (Cutleaf Ground Cherry), a native plant to tropical America, now widely distributed throughout the tropical, subtropical and warm temperate regions. It is an erect, branched, annual plant growing from 10 - 100cm tall. It harvested from the wild for its edible fruit, and also for medicinal use. Physalis angulata is known for its antimalarial, anti-inflammatory and post-partum treating properties. It contains physalins and withanolides. Pharmacological studies have shown anti-parasitic, anti-inflammatory, antimicrobial, anti-nociceptive, antimalarial, anti-leishmanial, immunosuppressive, anti-asthmatic, diuretic, and antitumor activities
|