Dehydrated Human Amnion/Chorion Membrane (dHACM) for Recovery After Fractionated Ablative CO2 Laser Resurfacing of the Face

Scarring Clinical Trial

Official title:

A Single Center, Double Blinded, Placebo Controlled, Randomized, Split Face Study to Evaluate the Efficacy of dHACM (Dehydrated Human Amnion Chorion Membrane) for Recovery After Fractionated Ablative CO2 Laser Resurfacing of the Face

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT01995604
• Other study ID #: EFLR001
• Status: Withdrawn
• Phase: N/A
• First received: November 21, 2013
• Last updated: June 12, 2014
• Start date: September 2013
• Est. completion date: December 2013

Study information

• Verified date: June 2014
• Source: MiMedx Group, Inc.
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to evaluate the efficacy of dHACM (Dehydrated Human Amnion Chorion Membrane) for reducing time to healing when used in post-laser recovery following ActiveFX™ and DeepFx™ fractionated ablative CO2 laser resurfacing of the face.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: December 2013
• Est. primary completion date: November 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. Male or female subjects in good general health greater than 18 years of age

2. Must be willing to agree to all terms of the protocol and provide a completed and signed informed consent, HIPAA and photography release forms

3. Subjects planning to undergo fractionated ablative CO2 laser resurfacing to the full face

4. Subject of either Fitzpatrick Skin Types I, II or III

• For female subjects of childbearing potential, they must have had a regular menstrual cycle prior to study entry and is willing to use an acceptable form of birth control during the entire course of the study. All systemic birth control measures must be in consistent use at least 30 days prior to entry into the study. A female is considered NOT to be of childbearing potential if she is postmenopausal for at least one (1) year, without a uterus and/or both ovaries, or has had a bilateral tubal ligation. Acceptable methods of birth control are: oral contraceptives, contraceptive patches/rings/implants Norplant, Depo-Provera, double-barrier methods (e.g. condoms and spermicide), abstinence and vasectomies of the partner.

5. Negative urine pregnancy test results at the time of study entry for females of childbearing potential, if applicable

6. Must be willing to comply with study instructions and complete the entire course of the study

Exclusion Criteria:

1. Any uncontrolled systemic disease that is not yet stabilized for at least one (1) year

2. A significant history or current evidence of a medical, psychological or other disorder that, in the investigator's opinion, would interfere with the objectives of the study

3. Recently excessive exposure to sunlight or artificial UV light (e.g.: use of tanning beds/booths and/or sunbathing) or expectations of tanning during the time of the study or has used self-tanner within 7 days of study entry

4. History of or the presence of any skin condition/disease that might interfere with the diagnosis or evaluation of study parameters (i.e., atopic dermatitis, eczema, psoriasis, seborrheic dermatitis)

5. Active bacterial, fungal, or viral infection

6. History of Herpes Simplex Virus to the facial and/or perioral areas

7. Known allergies or sensitivities to benzocaine, lidocaine, tetracaine, PABA (para-aminobenzoic acid), or other local anesthetics of the amide or ester family

8. Known allergies to gentamicin and/or streptomycin

9. Receiving any topical products containing alpha-hydroxy acids, salicylic acid, and Vitamins C or E (including derivatives of Vitamins C or E) on the face within 14 days prior to or during the study period, other than the ingredients of the study products

10. Receiving and/or has had a microdermabrasion (light or medium skin peel) treatment on their face within 30 days prior to or during the study period

11. Using any topical tretinoin product or derivative on their face within 12 weeks prior to or during the study period

12. Receiving a chemical peel, any systemic steroids, a non-ablative laser, light or radio frequency treatment and/or has had a Dermabrasion (deep skin peel) or ablative laser treatments on their face must have discontinued the drug/treatment and/or had the procedure at least 3 months prior to entering the study

13. History of keloids or hypertrophic scars

14. Use of systemic retinoids, prescription or over-the-counter grade within the past year

15. A female subject who is pregnant, nursing an infant or planning a pregnancy during the study

16. Current participation or completed participation of a clinical research study for an investigational drug or device within 30 days prior to the start of this study

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Scarring

Intervention

Other:
• Application of Sterile 0.9% Saline Solution
Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.
• Application of dHACM
Application of dHACM to half of face after UltraPulse laser therapy.

Locations

Country	Name	City	State
United States	Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc.	San Diego	California

Sponsors (1)

Lead Sponsor	Collaborator
MiMedx Group, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Pain Reduction		30 Days	No
Primary	The time to healing for both groups will be assessed as defined by appearance and 100% epithelialization.		Day 30	No
Secondary	Erythema, edema, crusting, and exudate will be compared between both groups.		30 Days	No