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Human Trial

Intradermal injections of a hair growth factor formulation for enhancement of human hair regrowth – safety and efficacy evaluation in a first- in -man pilot clinical study

 

ABSTRACT

Background: Research has shown the efficacy of hair growth factors in hair regrowth. We describe the intradermal injections of a recombinant, bioengineered hair formulation, containing growth factors, into the scalp skin, for enhancement of hair regrowth and evaluate its efficacy.

Objectives: The objective of this study was to assess the efficacy and safety of the hair growth factor formulation in reducing hair loss and enhancing hair growth.

Materials and methods: This was an open-label, prospective, single-arm interventional pilot study in which 1000 patients were given intradermal injections of a hair formulation into the scalp skin. The formulation contains vascular endothelial growth factor, basic fibroblast growth factor, insulin-like growth factor, keratinocyte growth factor, thymosin β 4, and copper tripeptide-1 suspended in a sterile injectable vehicle. Intradermal injections of this hair formulation were injected into the scalp once every 3 weeks for a total of eight such sessions. Hair pull test was performed before every session. Videomicroscopic and global images were taken at baseline, fourth session, eighth session, and 2 months after the completion of the eight sessions. Relevant safety assessments through
physical examination, questionnaires, and appropriate laboratory examination were conducted throughout the study.

Results: Significant reduction in hair fall was seen in 83% of the patients on hair pull test.
Videomicroscopic image evaluation showed that most patients had a decrease in the number of vellus hairs, increase in number of terminal hairs, and increase in shaft diameter. Seventy-five percent of the patients believed that the hair injections were aiding the treatment of their hair loss, and it was also beneficial in post-hair transplant patients. At 1 year, a statistically significant increase in total hair count ( P = 0.002) continued to be seen. Treatment was well tolerated.

Conclusions: Intradermal injections of this hair formulation may be a promising option for treating male as well as female patterns of hair loss.

QR678 Neo

The QR678® Neo therapy is a proprietary, first in class hair fall & hair regrowth therapy, which has revolutionized the treatment of hair fall in alopecia. This formulation was invented in India & has been named QR678 inspired by the new generation ubiquitous presence of “Quick Response“ QR code. 678 in Morse Code signifies “there is no answer”. This formulation has been named QR678® to signify a “Quick Response to a disease which earlier had no answer”.

The US and India patented QR678® Neo therapy is backed by 13+ clinical papers published in top international peer-reviewed journals. The biomimetic peptide formulation arrests hair fall & increases the thickness, number, and density of existing hair follicles leading to greater coverage in hair loss. The polypeptides used in the formulation mimic the action of specific human hair growth related growth factors that are naturally present in our scalp, making it natural growth factor-based treatment. The polypeptides penetrate deep into the scalp and provide nourishment to the scalp, which results in hair growth.

Exosomes

Exosomes are ‘signaling molecules’ that are injected into the scalp to trigger the secretion of growth factors. They are protein building blocks due to the presence of mRNA in their membrane. This mRNA synthesizes proteins according to its cell of origin. Therefore, when extracted from hair follicles, exosomes facilitate hair growth and can help prevent hair loss.

Exosomes: Promises or Pitfalls?

Although promising on paper, the research behind the rationale for exosome treatment is on-going. There is still a lot to learn about the efficacy and mechanism of action of exosome therapy. There is a need for reliable evidence in the form of research studies published in peer-reviewed journals with appropriate methodology to back the advent of exosome therapy for treatment of hair loss.

In the year 2019, the U.S. Food and Drug Administration issued a Public Safety Notification on exosome products stating the violative nature of “stem cells” products and their unsubstantiated claims in treating various conditions. The FDA clarified that currently there is no FDA-approved exosome product in the market.

How does it work?

The QR678® Neo therapy arrests hair fall & increases the thickness, number & density of existing hair follicles, leading to greater coverage in patients with alopecia. Since, the polypeptides used in QR678® Neo are anyways present in scalp full of hair (they get decreased in scalps which have hair fall), it is the enrichment of the scalp skin with these polypeptides which cause hair growth. Since these polypeptides are anyways normally present in the scalp, replenishing the scalp with these is not artificial and does not have any side effects

Unlike currently available hair fall treatments like minoxidil & finasteride, the QR678® Neo therapy is almost completely devoid of side effects. It is locally administered over the scalp skin by mesotherapy & as such is not absorbed into the systemic circulation. Unlike currently available hair transplant therapies like Follicular Unit Extraction (FUE) & Follicular Unit Transplantation (FUT), the QR678® Neo is non invasive, non surgical & therefore safer & more affordable. The QR678® Neo therapy works very well in androgenetic alopecia or male pattern baldness & female pattern hair loss. The QR678® Neo therapy has also demonstrated encouraging results in post chemotherapy induced hair loss, treatment of hair conditions like seborrheic dermatitis & in immunogenic diseases like alopecia areata.

Intellectual Property & Timelines:

The QR678® Neo storyline Serendipity has been the driving force behind this invention. Research into Retinoblastoma (a form of ocular cancer) brought out the side effects into focus, culminating into the formulation today known as QR678® Neo
 
Here is a link to more information on mechanism of administration of the QR678® Neo therapy:

Natural Ingredients Backed By Science

The QR678® Neo therapy is a proprietary, first-in-class therapy, backed by science that arrests hair fall & increases the thickness, number, and density of existing hair follicles leading to greater coverage in hair loss. The biomimetic polypeptides used in the formulation mimic the action of specific human hair growth related growth factors that are naturally present in our scalp, making it natural growth factor-based treatment. The polypeptides penetrate deep into the scalp and provide nourishment to the scalp, which results in hair growth. Unlike other treatments that contains minoxidil & finasteride, QR678® Neo therapy is completely devoid of side effects.

How Does It works

QR678® Neo Advantages

No side Effects
(Derived From Plants)

Quick & Effective
(Single Session in 10 Minutes)

Patented and Regulatory Approved in Multiple Geographies

13+ Published Researched Clinical Trials Demonstrating Efficacy

Non Surgical

About 90% Success Rate

Global Presence

Get Started with QR 678 neo

FAQ's

QR678® Neo consists of a proprietary blend of natural growth factors, identical to those found in a healthy scalp, ensuring its safety for universal application. This precise formulation contains targeted concentrations of specific factors known to promote hair growth. With QR678® Neo, patients experience no side effects. The treatment is administered on an outpatient basis, with visible results emerging as early as eight weeks after commencement. Hear directly from our patients about their experiences with the QR678® Neo hair loss treatment.

QR678® Neo treatments involve 5 to 10 sessions, spaced approximately 2-3 weeks apart. Visible improvements can be observed within a few weeks following the commencement of the therapy. Once optimal results are attained, further injections are unnecessary unless hair loss recurs. This enduring effect is due to QR678® Neo’s capacity to rejuvenate hair follicles. Discover the reasons behind QR678® Neo’s high efficacy in reducing hair loss and enhancing hair regrowth.

QR678® Neo offers a safe treatment experience without any side effects, enabling you to continue with your day-to-day activities right after each session. It is recommended to use a mild shampoo at least a day post-treatment and refrain from scratching or rubbing the area treated. If any concerns arise, consult your treatment provider for guidance.

  • Utilizing QR678® Neo in conjunction with hair transplant procedures has been shown to yield highly successful outcomes. QR678® Neo enhances hair density more rapidly and mitigates the shedding (catagen loss) of newly transplanted hair. The growth factors present in QR678® Neo contribute to quicker healing and reactivation of dormant hair follicles, thereby:
  • Enhancing the survival rate of hair follicles. Accelerating the tissue healing and repair process Revitalizing inactive hair follicles and promoting hair regrowth. Boosting the health of existing hair, making it fuller and stronger. QR678® Neo treatments can be administered in several sessions, starting three to four weeks post a successful hair transplant surgery. Additionally, QR678® Neo can be applied prior to hair transplant surgery to minimize the area needing transplantation and further improve the surgical outcomes.

Genetic hair loss, often hereditary and observed in both men and women, can indeed be managed effectively if treatment commences early. This type of hair loss, which frequently runs in families, typically follows a distinctive pattern: an M or W shape in men and thinning along the hair part in women. If you have a family history of patterned baldness, it’s crucial to monitor your hair health closely and consult a doctor at the first sign of hair loss.

There are several well-established treatments for genetic hair loss, including:

  • Topical and Oral Medications: Minoxidil, applied topically, and Finasteride, taken orally, are commonly prescribed to combat hair loss.
  • Hair Transplantation: Surgical options such as Follicular Unit Transplantation (FUT) and Follicular Unit Extraction (FUE) are effective methods for restoring hair.
  • Nutritional Supplements: Physicians may recommend hair growth supplements. Key nutrients like Vitamins A, C, and Biotin, along with minerals such as zinc and iron, are known to support hair health and reduce loss attributed to genetic factors.

Alopecia following chemotherapy is a widespread and emotionally impactful side effect of cancer treatments. The fear of hair loss often deters patients from undergoing necessary therapies. While hair loss from chemotherapy is usually temporary, regrowth can take months or even up to a year. However, recent advancements in treatment can expedite recovery:

  • Scalp Cooling: An FDA-approved method, particularly for breast cancer patients, scalp cooling can reduce chemotherapy’s impact on hair. It works by narrowing blood vessels in the scalp, lessening the amount of chemotherapy drugs reaching the hair follicles. The process involves a cooling unit that circulates coolant on the scalp, initiated about 30 minutes before chemotherapy begins. Side effects may include mild discomfort, nausea, and dry skin.
  • Topical Minoxidil: This medication enhances blood flow to the hair follicles, helping to prevent their shrinkage and encouraging hair retention.
  • QR678® Neo Hair Regrowth Treatment: FDA-approved and safe, QR678® Neo is effective in treating chemotherapy-induced alopecia in both men and women without side effects or discomfort. Clinical trials have demonstrated its efficacy, with results that can last a lifetime.

These treatments offer hope and options for those facing hair loss due to chemotherapy, providing a path to recovery and helping to mitigate one of the most challenging aspects of cancer treatment.

Life Changing Results