Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2

Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2: a Study on N(6)-Carboxymethyl-lysine, Interleukin 1-α, Dan Superoxide Dismutase in Stratum Corneum

The objective of this study is to evaluate the effect of Centella asiatica on hydration status of lower leg skin of DM type 2 patients by measuring SRRC and Skin Capacitance in correlation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum.

Study Overview

• Status: Unknown
• Conditions: Diabetes Mellitus, Type 2; Xerosis Cutis
• Intervention / Treatment: Drug: Topical CA; Drug: Petroleum jelly; Drug: Centella Asiatica Extract

Detailed Description

This ia a double blind randomized clinical trial on patients diagnosed with DM type 2 with dry skin to assess the effect of Centella asiatica (CA) on dry skin in corellation with AGEs CML, inflammation marker IL-1α, and oxidative stress SOD in stratum corneum after four weeks of treatment. Subjects are divided into three groups of treatment. The first group treated with oral CA and topical CA, second group treated with oral placebo and topical CA, and the last group treated with oral and topical placebo. The total subjects in each treatment groups are 53 subjects. The recruited subjects will be randomized to receive three different treatments, consist of 1. First group (A) will receive combination of oral CA at 2x1100 mg dose and 1% topical CA ointment. 2. Second group (B) will receive oral placebo and topical CA 1% ointment 3. Third group (C) will receive oral placebo and petroleum jelly as topical placebo The recruited subjects will still receive the prescribed treatment for DM type 2. The treatment for dry skin will be administered for 28 days. Randomization done by our supervisor using computer program (RandlistR) by assigning code number for each subjects. The procedures of treatment administration are explained below: 1. Every subject will receive 56 capsules and 10 gram of ointment to be used in 2 weeks period. Subjects will also receive explanation on how to take the drugs 2. Oral drug are taken 2 capsules (@ 550 mg) b.i.d over 12 hours. 3. The ointment is applied two times a day 15 minutes after bath time. 4. The application have to be distributed evenly on a specific 7 x 20 cms area on lower leg. All patients will be given plastic cover to determine the area. 5. The estimation of ointment applied on every leg is as much as ½ FTU or about 0,25 gram. 6. After 2 week period ended, subject will be given the same treatment at follow-up visit.

• Study Type: Interventional
• Enrollment (Actual): 159
• Phase: Phase 4

Contacts and Locations

Study Locations

• Indonesia
  • Jakarta
    • Jakarta Pusat, Jakarta, Indonesia, 10430
      • Universitas Indonesia

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 60 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Diagnosed with Diabetes Mellitus Type 2
• <60 years old by the end of the study
• suffered from dry skin on lower leg skin area, (minimum score= 3, measured using SRRC)
• agree to not use any skin care product orally or topically on lower leg skin and any other drugs (unless its part of diabetes mellitus management)
• normal ankle brachial index value ranged from 0.91-1.3

Exclusion Criteria:

• the presence of diabetic ulcer on one of patient's foot
• the presence of infection or dermatitis on the experimented foot
• the presence of severe inflammation on the experimented skin (redness score >2 or/and fissure score >2 measured by SRRC or/and total SRRC score ranged from12-16)
• estimated glomerular filtration rate value (eGFR) < 45
• impaired liver function (increased by 2x from upper limit reference for AST/ALT)

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Topical CA and Placebo Oral Drug; Patient given 10gr 1% CA ointment and 56 pcs of placebo drug	Drug: Topical CA; 1% centella asiatica ointment; Other Names: Centella asiatica ointment
Placebo Comparator: Petroleum Jelly and placebo oral drug; Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug	Drug: Petroleum jelly; vaseline album; Other Names: Topical Placebo
Experimental: Centella asiatica extract and Topical CA; Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA	Drug: Centella Asiatica Extract; centlla asiatica oral drug at 1100 mg dose; Other Names: Oral CA

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Skin Capacitance	SCap measured in (AU)	1 month (evaluated every 2 weeks)
Change in SOD	Superoxide Dismutase (compared to total protein)	1 month (evaluated every 2 weeks)
Change in IL-1α	Interleukin-1α (compared to total protein)	1 month (evaluated every 2 weeks)
Change in AGEs CML	Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)	1 month (evaluated every 2 week)
Change in SRRC	Specified symptom sum score. Measuring dry skin using four variables (scale, roughness, redness, and cracking) in score ranged from 1 to 4 for each variable. The highest the value marks the driest skin	1 month (evaluated every 2 week)

Collaborators and Investigators

• Sponsor: Indonesia University
• Investigators: Study Chair: Suhendro Suhendro, Doctor, Indonesia University

Study record dates

Study Major Dates

• Study Start (Actual): July 30, 2018
• Primary Completion (Actual): January 12, 2019
• Study Completion (Anticipated): June 30, 2019

Study Registration Dates

• First Submitted: January 18, 2019
• First Submitted That Met QC Criteria: January 20, 2019
• First Posted (Actual): January 24, 2019

Study Record Updates

• Last Update Posted (Actual): January 24, 2019
• Last Update Submitted That Met QC Criteria: January 20, 2019
• Last Verified: January 1, 2019

More Information

Terms related to this study

• Keywords: dry skin; centella asiatica; dm type 2; superoxide dismutase; AGEs CML; IL-1α
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 2; Dermatologic Agents; Emollients; Petrolatum
• Other Study ID Numbers: 441/UN2.F1/ETIK/2018/

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No