Chronic Arsenic PoisoningPhase 2NCT03127657
Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
A Phase 2 study testing Cock's comb extract 0.01% in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
Trial summary
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and topical moisturizing agent to the skin due to excellent moisturizing property. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Chronic Arsenic Poisoning
- What is being tested?
- Cock's comb extract 0.01%
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 25 participants
- Where
- 1 siteBangladesh
- Study dates
- 17 Jan 2016to 31 Jan 2018
- Phase
- Phase 2
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age: 18-60 years
- Sex: Both male and female
- Arsenical keratosis: Presence of severe keratosis (>5mm) in both palms
- Drinking arsenic contaminated water (>50 µg/L) for at least more than 6 months
- Patient voluntarily agreed to participate
- Patient who understood the instruction of applying drug and could apply drug as per as instruction
Who cannot join
- Age <18 and >60 years
- Pregnant and nursing mother
- Palmar psoriasis
- Eczema
- Any kind of systemic disease, inflammatory disease and infectious condition that affect skin for example diabetes mellitus, rheumatoid arthritis, systemic lupus erythrematosus, hepatitis
- Hypersensitivity to avain protein
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- Malignancy
- Impaired renal function - if creatinine level >1.3 mg/dl incase of men and >1.1 mg/dl in case of women
- Patient who received any treatment of arsenicosis within last three months
Trial locations and contacts
1 site in 1 country.
About this study
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and topical moisturizing agent to the skin due to excellent moisturizing property. It has anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the intensity of radioepithelitis. It is also used as a topical vehicle for the delivery of drug to the skin in actinic keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the skin. Therefore, the study will be conducted to determine any beneficial effect of topical application of cock's comb extract in the treatment of the patients with severe palmar arsenical keratosis.
Read the detailed description
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid is extensively utilized in many cosmetic products because of its moisturizing property as a topical moisturizing agent. It is also used as dermal fillers for wrinkle correction. It has anti-inflammatory effect and used in the treatment of different type of ulcers. In case of acute radioepithelitis, 0.2% hyaluronic acid is used to reduce inflammation. Hyaluronic acid has found important application in drug delivery system. Recently 3% diclofenac in 2.5% hyaluronic acid gel has been approved for the treatment of actinic keratoses as a unique topical vehicle for the localized delivery of drug to the skin. It is also used as a vehicle for various anticancer drugs. As it has many effective topical applications, it can be used in arsenical keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may cause repeated hydration of the skin as a result keratosis tends to soften and disappear. Therefore, the study will be conducted to identify the outcome of cock's comb extract in the treatment of arsenical skin lesion. Biological activity and cytotoxicity of cock's comb extract have been identified after performing brine shrimp bioassay test. Twenty-five patients with severe palmar (>5 mm) arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Before the study, water and nail samples will be collected to confirm arsenicosis. Blood samples will be collected for liver and kidney function test to observe any adverse effects of topically applied cock's comb extract both before and after the study. The cream will be prepared with 0.01% cock's comb extract mixed with olive oil, bee wax and benzoic acid for topical application 2 days prior visit of the recruited patients. The patient will be applied the cream on the affected area with a clean fingertip by rubbing gently at twice daily for 12 weeks without any interruption. Primary parameters will be the measurement of keratotic nodular size by slide calipers and perception scoring of the patients by Likert scale before and 12 weeks after the study. Secondary parameters will be the measurement of arsenic level in drinking water and nails of the recruited patients.
- Conditions
- Chronic Arsenic Poisoning
- Being tested
- Cock's comb extract 0.01%
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cock's comb extract 0.01%Drug
Also called Cock's comb extract cream
Applied topically twice daily for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Cock's comb extract 0.01% | Experimental | 25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks Receives: Drug: Cock's comb extract 0.01% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in palmer arsenical keratosis
Size of keratotic lesion will be decreased
Measured: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]
Secondary outcomes (1)
Changes in arsenic level in nail
Arsenic level in nail will be decreased
Measured: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2017
- Study start17 Jan 2016
- Primary completion31 Jan 2018
- Study completion31 Jan 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Arsenic PoisoningStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Topical application of cock's comb extract in the treatment of palmar arsenical keratosis
- Masking
- None (open label)
- Enrolment
- 25 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Prof. Mir Misbahuddin, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
- Investigators
- Fatema Chowdhury, MBBS, Principal investigator, Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03127657
- Sponsor's protocol ID
- BSMMU-011-CT
- Status last verified
- Jul 2018
- First submitted
- 12 Apr 2017
- Last updated
- 13 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Cock's Comb Extract in the Treatment of Arsenical Skin Lesion
- ClinicalTrials.gov ID
- NCT03127657
- Acronym / sponsor ID
- BSMMU-011-CT
- Conditions
- Chronic Arsenic Poisoning
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 25 participants (actual)
- Lead sponsor
- Bangabandhu Sheikh Mujib Medical University, Dhaka, BangladeshUniversity, hospital or other
- Study start
- 17 Jan 2016 (actual)
- Primary completion
- 31 Jan 2018 (actual)
- Study completion
- 31 Jan 2018 (actual)
- First posted
- 25 Apr 2017 (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.
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid acts as humectants and topical moisturizing agent to the skin due to excellent moisturizing property. It has anti-inflammatory effect and used in the treatment of ulcer healing and to reduce the intensity of radioepithelitis. It is also used as a topical vehicle for the delivery of drug to the skin in actinic keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may tends to decrease keratosis by repeated hydration of the skin. Therefore, the study will be conducted to determine any beneficial effect of topical application of cock's comb extract in the treatment of the patients with severe palmar arsenical keratosis.
Detailed description
Cock's comb extract is rich in hyaluronic acid, which is used as viscosupplementation injection and oral supplementation for osteoarthritis. Hyaluronic acid is extensively utilized in many cosmetic products because of its moisturizing property as a topical moisturizing agent. It is also used as dermal fillers for wrinkle correction. It has anti-inflammatory effect and used in the treatment of different type of ulcers. In case of acute radioepithelitis, 0.2% hyaluronic acid is used to reduce inflammation. Hyaluronic acid has found important application in drug delivery system. Recently 3% diclofenac in 2.5% hyaluronic acid gel has been approved for the treatment of actinic keratoses as a unique topical vehicle for the localized delivery of drug to the skin. It is also used as a vehicle for various anticancer drugs. As it has many effective topical applications, it can be used in arsenical keratosis. In the case of arsenical keratotic nodule, topical application of hyaluronic acid may cause repeated hydration of the skin as a result keratosis tends to soften and disappear. Therefore, the study will be conducted to identify the outcome of cock's comb extract in the treatment of arsenical skin lesion. Biological activity and cytotoxicity of cock's comb extract have been identified after performing brine shrimp bioassay test. Twenty-five patients with severe palmar (>5 mm) arsenical keratosis will be recruited on the basis of inclusion and exclusion criteria. Before the study, water and nail samples will be collected to confirm arsenicosis. Blood samples will be collected for liver and kidney function test to observe any adverse effects of topically applied cock's comb extract both before and after the study. The cream will be prepared with 0.01% cock's comb extract mixed with olive oil, bee wax and benzoic acid for topical application 2 days prior visit of the recruited patients. The patient will be applied the cream on the affected area with a clean fingertip by rubbing gently at twice daily for 12 weeks without any interruption. Primary parameters will be the measurement of keratotic nodular size by slide calipers and perception scoring of the patients by Likert scale before and 12 weeks after the study. Secondary parameters will be the measurement of arsenic level in drinking water and nails of the recruited patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Topical application of cock's comb extract in the treatment of palmar arsenical keratosis
| Arm | Type | Receives |
|---|---|---|
| Cock's comb extract 0.01% | Experimental | Drug: Cock's comb extract 0.01%25 Patients Cock's comb extract 0.01% Applied topically twice daily for 12 weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Age: 18-60 years
- Sex: Both male and female
- Arsenical keratosis: Presence of severe keratosis (>5mm) in both palms
- Drinking arsenic contaminated water (>50 µg/L) for at least more than 6 months
- Patient voluntarily agreed to participate
Key exclusion criteria (9 listed)
- Age <18 and >60 years
- Pregnant and nursing mother
- Palmar psoriasis
- Eczema
- Any kind of systemic disease, inflammatory disease and infectious condition that affect skin for example diabetes mellitus, rheumatoid arthritis, systemic lupus erythrematosus, hepatitis
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 |
|---|---|---|
| Cock's comb extract 0.01%Also: Cock's comb extract creamApplied topically twice daily for 12 weeks | Drug | Cock's comb extract 0.01% |
Primary outcome
Changes in palmer arsenical keratosis
Time frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]
Size of keratotic lesion will be decreased
1 secondary outcome
Changes in arsenic level in nail
Time frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: Yes]
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2018.
- Individual participant dataSharing planned: No
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.
Fatema Chowdhury, MBBS principal investigator
Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cock's comb extract 0.01% in people with Chronic Arsenic Poisoning, run by Bangabandhu Sheikh Mujib Medical University, Dhaka, Bangladesh at 1 site in Bangladesh.
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 6 inclusion and 9 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: finished, as of the sponsor's last update on 13 Jul 2018. 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 Bangladesh. 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. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Changes in palmer arsenical keratosis (time frame: [0 week (baseline), 12 weeks (end)] [ Safety Issue: No]] [Safety Issue: No]). 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 13 Jul 2018; AzTrials last refreshed its copy on 7 Nov 2026.