Efficacy and Safety of Biocellulose Sheet Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2013 by Chulalongkorn University
Sponsor:
Collaborator:
Agricultural Research Development Agency (Public Organization)
Information provided by (Responsible Party):
Pornanong Aramwit, Pharm.D., Ph.D, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01806831
First received: March 5, 2013
Last updated: September 29, 2013
Last verified: September 2013
  Purpose

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.


Condition Intervention
Skin Pigmentation
Skin Irritation
Device: "Biocellulose Mask", Farhorm®"

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Biocellulose Sheet From Coconut Juice Containing Anti-hyperpigmentation Agent ("Biocellulose Mask", "Farhorm®") in Patients Receiving Laser Treatment

Further study details as provided by Chulalongkorn University:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: April 2014 (Final data collection date for primary outcome measure)
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).

  Eligibility

Ages Eligible for Study:   20 Years to 50 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01806831

Contacts
Contact: Pornanong Aramwit, Pharm.D., Ph.D. +6689-921-7255 aramwit@gmail.com

Locations
Thailand
Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity Recruiting
Bangkok, Thailand, 10310
Contact: Pornanong Aramwit, Pharm.D., Ph.D.    +6689-921-7255    aramwit@gmail.com   
Principal Investigator: Pornanong Aramwit, Pharm.D., Ph.D.         
Sponsors and Collaborators
Chulalongkorn University
Agricultural Research Development Agency (Public Organization)
  More Information

No publications provided

Responsible Party: Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier: NCT01806831     History of Changes
Other Study ID Numbers: CU 12-33-009
Study First Received: March 5, 2013
Last Updated: September 29, 2013
Health Authority: Thailand: Ethical Committee

Additional relevant MeSH terms:
Hyperpigmentation
Pigmentation Disorders
Skin Diseases

ClinicalTrials.gov processed this record on September 18, 2014