Back to resultsEfficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Primary Purpose
Skin Pigmentation, Skin Irritation
Status
Completed
Phase
Not Applicable
Locations
Thailand
Study Type
Interventional
Intervention
"Biocellulose Mask", Farhorm®"
Sponsored by
About this trial
This is an interventional treatment trial for Skin Pigmentation
Eligibility Criteria
Inclusion Criteria:
- Age 20-50 years old
- No skin problem such as inflammation, fresh wounds
- Not receive laser treatment during last 3 months
- No history of smoking or alcohol drinking
- No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate
- Willing to participate in this study and can comply with study protocol
Exclusion Criteria:
- Has history of hyperallergic reaction
- Has wound(s) on face during last 4 weeks
- Has history of eczema, psoriasis during last 6 months
- Has laser treatment during last month
- Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting
- Had major surgery during last 12 months
- Has history of cancer during last 12 months
- Pregnant or lactation
Sites / Locations
- Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
Outcomes
Primary Outcome Measures
The skin pigmentation immediately after laser therapy and after using biocellulose mask
Secondary Outcome Measures
Full Information
NCT ID
NCT01806831
First Posted
March 5, 2013
Last Updated
March 10, 2015
Sponsor
Chulalongkorn University
Collaborators
Agricultural Research Development Agency (Public Organization)
1. Study Identification
Unique Protocol Identification Number
NCT01806831
Brief Title
Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Official Title
Efficacy and Safety of Biocellulose Sheet From Coconut Juice Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
Study Type
Interventional
2. Study Status
Record Verification Date
March 2015
Overall Recruitment Status
Completed
Study Start Date
September 2012 (undefined)
Primary Completion Date
April 2014 (Actual)
Study Completion Date
June 2014 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Chulalongkorn University
Collaborators
Agricultural Research Development Agency (Public Organization)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The laser areas treated with biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask", "Farhorm®") heal faster than vaseline ointment which is a standard treatment.
Detailed Description
Volar surface at upper arm (2X2 cm) on both sides were treated with semi ablative, 1,550 nm Erbium: glass fractional laser. Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent ("biocellulose mask","Farhorm®")was applied for 20 min on one side and the other side was treated with vaseline ointment. The redness, skin hydration and skin pigmentation were evaluated at that area before laser, immediately after laser and after applying the treatment. These parameters were compared between treatment (area treated with Biocellulose sheet from coconut juice containing anti-hyperpigmentation agent, "biocellulose mask", "Farhorm®") and control (vaseline ointment).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Pigmentation, Skin Irritation
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Intervention Type
Device
Intervention Name(s)
"Biocellulose Mask", Farhorm®"
Primary Outcome Measure Information:
Title
The skin pigmentation immediately after laser therapy and after using biocellulose mask
Time Frame
Change from immediately after laser treatment and 30 min after laser and treatment with mask
10. Eligibility
Sex
All
Minimum Age & Unit of Time
20 Years
Maximum Age & Unit of Time
50 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Age 20-50 years old
No skin problem such as inflammation, fresh wounds
Not receive laser treatment during last 3 months
No history of smoking or alcohol drinking
No allergy to licorice extract, Vit C, Vit E, arbutin or stearyl glycyrrhetinate
Willing to participate in this study and can comply with study protocol
Exclusion Criteria:
Has history of hyperallergic reaction
Has wound(s) on face during last 4 weeks
Has history of eczema, psoriasis during last 6 months
Has laser treatment during last month
Use steroid, antibiotic, anti-inflammatory drugs or antihistamine during 3 days before recruiting
Had major surgery during last 12 months
Has history of cancer during last 12 months
Pregnant or lactation
Facility Information:
Facility Name
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity
City
Bangkok
ZIP/Postal Code
10310
Country
Thailand
12. IPD Sharing Statement
Learn more about this trial
Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment
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