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

Skin Irritation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01806831
• Other study ID #: CU 12-33-009
• Status: Completed
• Phase: N/A
• First received: March 5, 2013
• Last updated: March 10, 2015
• Start date: September 2012
• Est. completion date: June 2014

Study information

• Verified date: March 2015
• Source: Chulalongkorn University
• Contact: n/a
• Is FDA regulated: No
• Health authority: Thailand: Ethical Committee
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 50 Years

Eligibility

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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperpigmentation
• Skin Irritation
• Skin Pigmentation

Intervention

Device:
• "Biocellulose Mask", Farhorm®"

Locations

Country	Name	City	State
Thailand	Department of Pharmacy Practice, Faculty of Pharmaceutical Sciences, Chulalongkorn Unviersity	Bangkok

Sponsors (2)

Lead Sponsor	Collaborator
Chulalongkorn University	Agricultural Research Development Agency (Public Organization)

Country where clinical trial is conducted

Thailand, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes