NCT01806831

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2012

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2012

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 5, 2013

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 7, 2013

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2014

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

March 11, 2015

Status Verified

March 1, 2015

Enrollment Period

1.6 years

First QC Date

March 5, 2013

Last Update Submit

March 10, 2015

Conditions

Skin PigmentationSkin Irritation

Outcome Measures

Primary Outcomes (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

Interventions

"Biocellulose Mask", Farhorm®"DEVICE

Eligibility Criteria

Age20 Years - 50 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity

Bangkok, Bangkok, 10310, Thailand

Location

MeSH Terms

Conditions

Pigmentation Disorders

Condition Hierarchy (Ancestors)

Skin DiseasesSkin and Connective Tissue DiseasesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate Professor

Study Record Dates

First Submitted

March 5, 2013

First Posted

March 7, 2013

Study Start

September 1, 2012

Primary Completion

April 1, 2014

Study Completion

June 1, 2014

Last Updated

March 11, 2015

Record last verified: 2015-03

Locations

TH(1)