Xerosis CutisPhase 4NCT03815305
Effect of Centella Asiatica on Xerotic Skin in Diabetes Mellitus Type 2
A Phase 4 study testing Centella Asiatica Extract, Topical CA and Petroleum jelly in people with Xerosis Cutis and Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
Trial summary
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. Read more about this study
- Who is it for?
- Ages Up to 60 years
- Conditions the study is for
- Xerosis Cutis, Diabetes Mellitus, Type 2
- What is being tested?
- Centella Asiatica Extract, Topical CA and Petroleum jelly
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 159 participants
- Where
- 1 siteIndonesia
- Study dates
- 30 Jul 2018to 30 Jun 2019
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Up to 60 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Universitas Indonesia
Jakarta Pusat, Jakarta Special Capital Region, 10430
About this study
Official title: 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.
Read the 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.
- Conditions
- Xerosis Cutis, Diabetes Mellitus, Type 2
- Being tested
- Centella Asiatica Extract, Topical CA, Petroleum jelly
- Keywords
- dry skin, dm type 2, centella asiatica, superoxide dismutase, AGEs CML, IL-1α
- Medical subject headings
- Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Centella Asiatica ExtractDrug
Also called Oral CA
centlla asiatica oral drug at 1100 mg dose
Topical CADrug
Also called Centella asiatica ointment
1% centella asiatica ointment
Petroleum jellyDrug
Also called Topical Placebo
vaseline album
| Study group | Role | What they receive |
|---|---|---|
| Topical CA and Placebo Oral Drug | Active comparator | Patient given 10gr 1% CA ointment and 56 pcs of placebo drug Receives: Drug: Topical CA |
| Petroleum Jelly and placebo oral drug | Placebo comparator | Patient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug Receives: Drug: Petroleum jelly |
| Centella asiatica extract and Topical CA | Experimental | Patient given 10gr 1% CA ointment and 56 pcs of drug containing CA Receives: Drug: Centella Asiatica Extract |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Skin Capacitance
SCap measured in (AU)
Measured: 1 month (evaluated every 2 weeks)
Change in SOD
Superoxide Dismutase (compared to total protein)
Measured: 1 month (evaluated every 2 weeks)
Change in IL-1α
Interleukin-1α (compared to total protein)
Measured: 1 month (evaluated every 2 weeks)
Change in AGEs CML
Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)
Measured: 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
Measured: 1 month (evaluated every 2 week)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jan 2019
- Study start30 Jul 2018
- Primary completion12 Jan 2019
- Study completion30 Jun 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Xerosis CutisStudies of the same condition, open and under way.
- More trials run by Universitas IndonesiaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 159 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Indonesia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Lili Legiawati, SpKK(K), Universitas Indonesia
- Investigators
- Suhendro Suhendro, Doctor, Study chair, Universitas Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03815305
- Sponsor's protocol ID
- 441/UN2.F1/ETIK/2018/
- Status last verified
- Jan 2019
- First submitted
- 18 Jan 2019
- Last updated
- 24 Jan 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT03815305
- Acronym / sponsor ID
- 441/UN2.F1/ETIK/2018/
- Conditions
- Xerosis Cutis, Diabetes Mellitus, Type 2
- Keywords
- dry skin, dm type 2, centella asiatica, superoxide dismutase, AGEs CML, IL-1α
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 159 participants (actual)
- Lead sponsor
- Universitas IndonesiaUniversity, hospital or other
- Study start
- 30 Jul 2018 (actual)
- Primary completion
- 12 Jan 2019 (actual)
- Study completion
- 30 Jun 2019 (estimated)
- First posted
- 24 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Topical CA and Placebo Oral Drug | Active comparator | Drug: Topical CAPatient given 10gr 1% CA ointment and 56 pcs of placebo drug |
| Petroleum Jelly and placebo oral drug | Placebo comparator | Drug: Petroleum jellyPatient given 10gr petroleum jelly 100% topical ointment and 56 pcs of placebo drug |
| Centella asiatica extract and Topical CA | Experimental | Drug: Centella Asiatica ExtractPatient given 10gr 1% CA ointment and 56 pcs of drug containing CA |
Who may qualify
- Ages
- Up to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Centella Asiatica ExtractAlso: Oral CAcentlla asiatica oral drug at 1100 mg dose | Drug | Centella asiatica extract and Topical CA |
| Topical CAAlso: Centella asiatica ointment1% centella asiatica ointment | Drug | Topical CA and Placebo Oral Drug |
| Petroleum jellyAlso: Topical Placebovaseline album | Drug | Petroleum Jelly and placebo oral drug |
Primary outcome
Change in Skin Capacitance
Time frame: 1 month (evaluated every 2 weeks)
SCap measured in (AU)
Change in SOD
Time frame: 1 month (evaluated every 2 weeks)
Superoxide Dismutase (compared to total protein)
Change in IL-1α
Time frame: 1 month (evaluated every 2 weeks)
Interleukin-1α (compared to total protein)
Change in AGEs CML
Time frame: 1 month (evaluated every 2 week)
Advanced Glycation End Product, N-(Carboxymethyl)lysine (compared to total protein)
Change in SRRC
Time frame: 1 month (evaluated every 2 week)
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jan 2019.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Suhendro Suhendro, Doctor study chair
Universitas Indonesia
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Centella Asiatica Extract, Topical CA and Petroleum jelly in people with Xerosis Cutis and Diabetes Mellitus, Type 2, run by Universitas Indonesia at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Skin Capacitance (time frame: 1 month (evaluated every 2 weeks)). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jan 2019.