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

NCT ID: NCT01995604

Last Updated: 2014-06-13

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2013-09-30
• Study Completion Date: 2013-12-31

Brief 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.

Conditions

Scarring

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

dHACM

UltraPulse laser therapy with application of dHACM

Group Type: EXPERIMENTAL

Application of dHACM

Intervention Type: OTHER

Application of dHACM to half of face after UltraPulse laser therapy.

Sterile 0.9% Saline Solution

UltraPulse laser therapy with application of Sterile 0.9% Saline Solution

Group Type: PLACEBO_COMPARATOR

Application of Sterile 0.9% Saline Solution

Intervention Type: OTHER

Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.

Interventions

Application of Sterile 0.9% Saline Solution

Application of Sterile 0.9% Saline Solution to half of face after UltraPulse laser therapy.

Intervention Type: OTHER

Application of dHACM

Application of dHACM to half of face after UltraPulse laser therapy.

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

MiMedx Group, Inc.

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mitchel P Goldman, MD

Role: PRINCIPAL_INVESTIGATOR

Dermatology Cosmetic Laser Medical Associates of La Jolla, Inc.

Locations

Dermatology Cosmetic Laser Medical Associates of LaJolla, Inc.

San Diego, California, United States

Countries

United States

Other Identifiers

EFLR001

Identifier Type: -

Identifier Source: org_study_id