Practice
Navara Health, PLLC
5301 Alpha Road, Suite 34, Room 21
Dallas, Texas 75240
Contact
469-653-3124
contact@navarahealthtx.com
Treating Provider
Jessica Boggs, MSN, APRN, FNP-C, ENP-C
Aesthetic RN
Rocio Gonzalez, RN
Under APRN delegation & GFE oversight
Medical Director
Simal Patel, MD
Product
VAMP™ Advanced (Prollenium)
Service Location
Dallas, Texas (In-Clinic Only · Adults 18+)
Purpose of This Consent
I am electing to receive VAMP™ Advanced bio-revitalizing topical therapy at Navara Health as an adjunct to microneedling, radiofrequency (RF) microneedling, or other compatible skin-resurfacing procedures. This document explains the nature of the product, the topical application method, ingredients, potential benefits, known and unknown risks, alternatives, and limitations.
Procedure-specific consent. This consent is in addition to, and where it conflicts, controls over, the Navara Health General Aesthetic Consent and any companion procedure consent (such as the Microneedling Consent or Vampire Facial® Consent if applicable). VAMP™ is applied topically only following the skin-disrupting procedure that creates microchannels for product penetration.
Product Description
VAMP™ Advanced is a sterile, pre-mixed, single-use, patent-pending bio-revitalizing topical solution manufactured by Prollenium Medical Technologies. The product is formulated to support skin rejuvenation when applied to skin that has been micro-injured through microneedling, RF microneedling, or similar disruptive procedures. The transient micro-channels created during these procedures allow the ingredients to penetrate deeper than would occur with topical application to intact skin.
Mechanism of Action (Manufacturer Claims)
- Support skin tonicity and texture
- Improve hydration and elasticity
- Reduce visible appearance of fine lines and wrinkles
- Tighten pores
- Restore skin's overall glow
Complete Ingredient Profile
11 Vitamins
Vitamins
Support hydration, skin elasticity, and overall skin revitalization.
23 Amino Acids
Amino Acids
Building blocks of skin proteins; reduce appearance of aging and improve skin tonicity.
6 Minerals
Minerals
Support skin barrier function and overall skin health.
Medical Grade
PDRN (Polydeoxyribonucleotides)
Low molecular weight DNA fragments derived from wild salmon, purified to over 95% medical grade. Manufacturer claims include skin tightening and improved elasticity.
HA
Hyaluronic Acid
Provides hydration and supports moisture retention.
Application Method & Critical Use Restriction
Critical · Topical Application Only
I understand and acknowledge that VAMP™ Advanced is being applied TOPICALLY ONLY at Navara Health, in accordance with the manufacturer's labeling and intended use. The product is applied to the skin's surface immediately following microneedling, RF microneedling, or a compatible micro-disruptive procedure that creates transient micro-channels in the epidermis.
VAMP™ is NOT injected at Navara Health. Injection of this product is outside the manufacturer's labeling and is not part of the procedure I am consenting to today.
Procedure Sequence
- The skin is cleansed and prepared per the standard pre-procedure protocol
- A topical anesthetic may be applied as appropriate (separate consent considerations apply)
- Microneedling or RF microneedling is performed (separate procedure consent required)
- VAMP™ Advanced is applied topically to the treated skin during and/or immediately following the microneedling step
- Post-procedure care instructions are reviewed
FDA & Regulatory Status
I understand and acknowledge that:
- VAMP™ Advanced is not FDA-approved as a drug or device for the treatment, cure, or prevention of any disease or skin condition
- The product is positioned as a topical bio-revitalizing solution, used at the licensed provider's discretion in the context of an aesthetic procedure
- Outcomes described in manufacturer materials are based on clinical studies that may not have been reviewed by the FDA
- The FDA has not specifically evaluated VAMP™ Advanced for safety or efficacy in the indications described
- Use of VAMP™ as a post-microneedling topical adjunct is consistent with manufacturer labeling and standard aesthetic medicine practice, but is not an FDA-approved therapy
Expected Results & Limitations
- Visible results typically develop gradually over 2–6 weeks following the procedure as skin remodeling occurs
- Multiple sessions (often 2–4 spaced 3–6 weeks apart) are typically recommended for the initial course; maintenance every 3–6 months may be advised
- Results vary significantly between individuals based on skin condition, age, lifestyle, sun exposure, smoking, hormonal status, and concurrent skincare
- VAMP™ is one part of a comprehensive skin-rejuvenation approach; it is not a standalone cure or one-time treatment
- No specific outcome is guaranteed
Risks & Possible Complications
Common / Expected
Post-Procedure Effects
Redness, mild swelling, and warmth at treatment site (typically resolves in 24–72 hours). Mild stinging or tingling during application. Skin sensitivity. Mild flaking, dryness, or peeling 2–7 days post-procedure. Pinpoint bleeding or crusting from the microneedling step (not the VAMP™ application itself). Mild temporary hyperpigmentation in darker skin types.
Less Common
Possible Reactions
Local allergic or hypersensitivity reaction to one or more ingredients. Contact dermatitis. Persistent redness lasting more than 1 week. Acne-like breakout or perifollicular irritation. Mild infection (typically related to post-procedure care). Reactivation of cold sores (herpes simplex) — prophylactic antiviral may be advised for patients with a history. Tram-tracking or temporary visible micro-channel patterns. Post-inflammatory hyperpigmentation, particularly in Fitzpatrick types IV–VI.
Rare but Serious
Significant Risks
Severe allergic reaction or anaphylaxis — particularly relevant given the salmon-derived PDRN component (see Section 6). Severe contact dermatitis. Significant infection requiring antibiotics. Scarring or persistent hyperpigmentation (very rare with proper technique and post-procedure care). Granulomatous reaction. Unforeseen reactions to the bio-revitalizing formulation. Long-term safety of repeated PDRN exposure in humans is not fully established.
Salmon Allergy Disclosure & Safety Screen
Critical Safety Disclosure
VAMP™ Contains PDRN Derived From Wild Salmon
The PDRN (polydeoxyribonucleotide) component of VAMP™ Advanced is derived from wild salmon. While the PDRN is purified to over 95% medical-grade purity to remove allergenic proteins, the source material is fish, and salmon is one of the FDA-recognized major food allergens.
Patients with severe fish allergies — particularly anaphylactic-type reactions to salmon, trout, or other finfish — may be at elevated risk of allergic reaction with VAMP™ treatment. Even purified products can theoretically contain trace allergenic protein.
I am being asked to confirm my allergy status to fish, salmon, or other seafood before treatment.
Option A · I have NO known fish or salmon allergy
I have no known allergy to salmon, trout, finfish, or shellfish. I have not experienced any prior allergic reaction to fish or fish-derived products. I am comfortable proceeding with VAMP™ Advanced treatment.
Option B · I have a mild fish sensitivity but no severe reactions
I have a known mild fish sensitivity or have experienced minor reactions (such as mild GI discomfort or skin sensitivity) but have never experienced anaphylaxis, throat swelling, or severe breathing difficulty from fish or fish-derived products. I have discussed this with my provider, who has determined I am a candidate. I accept the elevated risk of allergic reaction.
Option C · I have a documented salmon or finfish allergy
I have a documented allergy to salmon or finfish that has resulted in significant allergic reaction (hives, swelling, anaphylaxis, or required emergency medical care). I understand that I am NOT a candidate for VAMP™ Advanced at this time, and an alternative post-microneedling topical will be discussed with my provider.
I acknowledge that misrepresenting my allergy history may result in serious harm to me and increases the risk of severe allergic reaction. By initialing my selected option above and signing below, I confirm my allergy disclosure is accurate.
Patient Signature (Salmon Allergy Disclosure)
Contraindications & Cautions
VAMP™ treatment may be contraindicated, deferred, or modified if I have or disclose:
- Documented salmon or finfish allergy with significant reaction history (see Section 6)
- Active skin infection, open wound, severe acne, or untreated dermatitis at the treatment site
- Active herpes simplex outbreak at the treatment site
- Pregnancy, possible pregnancy, or breastfeeding (out of caution due to limited safety data)
- Active autoimmune disease affecting the skin (lupus, scleroderma, vitiligo with active progression)
- Active cancer or recent oncology treatment (case-by-case review)
- Bleeding or clotting disorders, or current anticoagulant therapy (increased post-microneedling bruising risk)
- Isotretinoin (Accutane) use within the previous 6–12 months
- Recent dermatologic procedures (chemical peels, lasers, deep microneedling) in the past 2 weeks
- Recent or planned tanning or significant sun exposure
- Known allergy to any other ingredient component (vitamins, amino acids, hyaluronic acid)
- History of keloid or hypertrophic scarring
- History of post-inflammatory hyperpigmentation
- Active substance use disorder (clinical judgment)
Pre- and Post-Procedure Responsibilities
Before Treatment
- Disclose all known allergies, especially to salmon, finfish, or any product ingredient
- Disclose all medications, supplements, blood thinners, and recent dermatologic procedures
- Discontinue retinoids, exfoliating acids (AHA/BHA), and harsh active ingredients for 3–5 days before treatment
- Avoid significant sun exposure or tanning beds for 1 week before
- Arrive with clean skin, free of makeup, sunscreen, and skincare products
- Notify provider of cold sore history (prophylactic antiviral may be recommended)
After Treatment
- Avoid touching, picking, or scrubbing the treated area for 24–48 hours
- Use only gentle, fragrance-free cleansers and a recommended post-procedure moisturizer
- Avoid makeup, active skincare, retinoids, and exfoliating acids for 3–5 days
- Apply SPF 30+ sunscreen daily (mineral preferred during recovery) — sun protection is critical given micro-channel healing
- Avoid strenuous exercise, saunas, hot tubs, and significant heat exposure for 24–48 hours
- Sleep with head elevated the first night if comfortable
- Drink plenty of water and prioritize healthy nutrition to support skin recovery
- Do not pick at any small scabs, crusts, or flaking that may form during recovery
Call Navara Health Immediately For
- Hives, facial swelling, throat tightness, or difficulty breathing (possible anaphylaxis — call 911 first)
- Spreading redness, fever, drainage, or signs of infection
- Severe persistent pain beyond the first 48 hours
- Significant prolonged swelling (more than 5–7 days)
- Any reaction I am uncertain about
For life-threatening allergic symptoms, call 911 immediately, then notify Navara Health.
Alternatives
Alternatives to VAMP™ Advanced topical bio-revitalization include, but are not limited to:
- No treatment
- Microneedling alone (without bio-revitalizing topical)
- Microneedling with PRP (Vampire Facial® or autologous platelet-rich plasma)
- Other bio-revitalizing or growth-factor topicals (non-PDRN-containing)
- Topical-only skin rejuvenation protocols (medical-grade skincare, retinoids, vitamin C)
- Chemical peels
- Laser or light-based skin treatments
- Injectable treatments (filler, biostimulators, neurotoxin) for related concerns
I may decline VAMP™ treatment at any time, including before the procedure begins.
Financial Disclosure
- VAMP™ treatment is elective and not covered by insurance
- Navara Health is a cash-pay practice and does not bill, verify, or submit claims to insurance
- Payment is due at the time of service
- No refunds are issued once the VAMP™ syringe has been opened or any portion of the protocol has been initiated
- Pre-paid treatment series and packages are non-refundable except as expressly stated in writing
- Maintenance treatments and additional sessions are at additional cost
- Treatment of complications (antibiotics, antiviral, allergic reaction management) may incur additional cost
Communication & HIPAA Authorization
I authorize Navara Health to communicate with me regarding scheduling, pre/post-procedure instructions, follow-up, and adverse event reporting through:
- The secure HIPAA-compliant patient portal
- Email to the address I have provided
- SMS / text message to the mobile number I have provided
- Telephone calls to the number I have provided
I understand that email and SMS are not fully secure channels. I may revoke authorization for any specific channel in writing to contact@navarahealthtx.com, except where required for legally mandated notices.
Assumption of Risk & Release of Liability
I voluntarily assume all known, unknown, and unforeseen risks associated with VAMP™ Advanced bio-revitalizing topical therapy. To the fullest extent permitted by law, I agree to release, indemnify, and hold harmless Navara Health, PLLC, Jessica Boggs APRN, Rocio Gonzalez RN, the medical director, and all affiliated providers, nurses, staff, contractors, and agents from liability related to:
- Adverse reactions or complications
- Allergic reactions (including reactions related to salmon-derived PDRN, where allergy was not disclosed accurately)
- Lack of improvement or treatment failure
- Cosmetic dissatisfaction with the result
- Need for additional, corrective, or maintenance procedures
- Long-term or delayed effects not yet known to medicine
- Conditions or allergies not disclosed prior to treatment
This release does not apply to cases of gross negligence or willful misconduct, and does not waive any right that cannot lawfully be waived under the laws of the State of Texas.
Dispute Resolution & Binding Arbitration
Any dispute, controversy, or claim arising out of or relating to this Consent, the procedure performed, or the practitioner-patient relationship — including any claim of medical malpractice, billing dispute, or breach of contract — shall first be addressed by good-faith negotiation between the parties.
If the matter cannot be resolved through negotiation within thirty (30) days, the parties agree to submit the dispute to binding arbitration administered by a recognized arbitration body (such as the American Arbitration Association) under its applicable rules, with the arbitration to take place in Dallas County, Texas.
The parties acknowledge that by agreeing to arbitration, they are waiving the right to a jury trial. This provision does not waive any right that cannot lawfully be waived under Texas law. Either party retains the right to seek injunctive or equitable relief in court where appropriate.
Governing Law & Severability
This Consent shall be governed by and construed under the laws of the State of Texas. If any provision is found unenforceable, the remaining provisions shall remain in full force and effect.
Patient Initials — Required for Each Critical Clause
Each of the following requires my separate written initials. By initialing, I confirm that I understand and agree to each individual clause.
I understand that VAMP™ Advanced is being applied topically only following microneedling/RF microneedling, in accordance with the manufacturer's labeling, and that VAMP™ is not injected at Navara Health.
I understand that VAMP™ Advanced contains PDRN derived from wild salmon, that I have accurately disclosed my allergy status in Section 6, and that misrepresentation of my fish allergy status may result in serious harm.
I understand that VAMP™ Advanced is not FDA-approved for the treatment, cure, or prevention of any disease or skin condition, and that results are not guaranteed.
I understand that multiple sessions (2–4 spaced 3–6 weeks apart) are typically required for visible results, with maintenance every 3–6 months, at additional cost.
I understand that no refunds are issued once the syringe has been opened or any portion of the protocol has been initiated.
I agree to binding arbitration as described in Section 13 and understand that I am waiving the right to a jury trial.
Photography & Marketing Authorization
Photographs of the face/treatment area taken before, during, and after VAMP™ Advanced treatment serve different purposes, and I am being asked to provide separate consent for each use. I understand I may consent to medical documentation while declining marketing use, or vice versa.
Photography Use — Please Initial Each Option
Required · Medical Documentation
I consent to clinical photographs of the treatment area being taken before, during, and after services for the purpose of medical documentation, treatment planning, progress tracking, and inclusion in my confidential medical record. These photographs will not be shared outside the practice without further written authorization.
Optional · Marketing & Promotional Use
I additionally authorize Navara Health, PLLC to use my before/after photographs in marketing materials, including the practice website, social media (Instagram, Facebook, TikTok, etc.), printed materials, advertisements, and educational content. My face may be identifiable in these images. No compensation will be provided. I may revoke this authorization at any time in writing, and Navara Health will stop using the images going forward, though I understand previously published images cannot always be recalled from third parties or the internet.
Optional · De-Identified Marketing Use Only
I authorize use of my before/after photographs in marketing materials only with my face de-identified (eyes/identifying features cropped or obscured). I do not authorize identifiable images for marketing.
Optional · Provider Education & Conferences
I authorize use of my before/after photographs (identifiable or de-identified, as initialed above) in professional education contexts, including conferences, clinician training, peer education, and published case reports.
Patient Signature (Photography & Marketing)
Patient Acknowledgment & Electronic Consent
By signing below (or by typing my full legal name as an electronic signature), I acknowledge and affirm:
- I am at least 18 years of age.
- I have read this VAMP™ Advanced Informed Consent in its entirety.
- I fully understand the product, ingredients, application method, risks, benefits, limitations, and alternatives.
- I understand VAMP™ is applied topically only at Navara Health and is not injected.
- I have accurately disclosed my fish and salmon allergy status in Section 6.
- I have had the opportunity to ask questions, and all questions have been answered to my satisfaction.
- I have disclosed my complete medical history, allergies, medications, supplements, and recent procedures.
- I understand that results are not guaranteed and that multiple sessions may be required.
- I accept full financial responsibility and understand that no refunds are issued once the protocol has been initiated.
- I authorize communication through the channels described in Section 11.
- I voluntarily assume all known and unknown risks and agree to the release of liability described in Section 12.
- I agree to binding arbitration as described in Section 13 and understand that I am waiving the right to a jury trial.
- I have completed the separate Salmon Allergy Disclosure, the Patient Initials block, and the Photography & Marketing Authorization above.
- I voluntarily consent to VAMP™ Advanced topical bio-revitalizing treatment at Navara Health, PLLC.
- My typed name serves as my legal electronic signature, equivalent to a handwritten signature, and this consent becomes part of my permanent medical record.
Treatment Session (Visit # of Series)
Patient Signature (or Typed Electronic Signature)
Provider / Performing Clinician Signature