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

Sponsor
Chulalongkorn University (Other)
Overall Status
Completed
CT.gov ID
NCT01806831
Collaborator
Agricultural Research Development Agency (Public Organization) (Other)
30
Enrollment
1
Location
21
Duration (Months)
1.4
Patients Per Site Per Month

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: "Biocellulose Mask", Farhorm®"
 N/A

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).

Study Design

Study Type:
Interventional
Actual Enrollment :
30 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (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
Study Start Date :
Sep 1, 2012
Actual Primary Completion Date :
Apr 1, 2014
Actual Study Completion Date :
Jun 1, 2014

Outcome Measures

Primary Outcome Measures

  1. The skin pigmentation immediately after laser therapy and after using biocellulose mask [Change from immediately after laser treatment and 30 min after laser and treatment with mask]

Eligibility Criteria

Criteria

Ages Eligible for Study:
20 Years to 50 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
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

Locations

Site City State Country Postal Code
1 Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity Bangkok Thailand 10310

Sponsors and Collaborators

  • Chulalongkorn University
  • Agricultural Research Development Agency (Public Organization)

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Pornanong Aramwit, Pharm.D., Ph.D, Associate Professor, Chulalongkorn University
ClinicalTrials.gov Identifier:
NCT01806831
Other Study ID Numbers:
  • CU 12-33-009
First Posted:
Mar 7, 2013
Last Update Posted:
Mar 11, 2015
Last Verified:
Mar 1, 2015
Additional relevant MeSH terms:
Hyperpigmentation

Study Results

No Results Posted as of Mar 11, 2015