According to the pharmaceutical and biotech industry on the 1st, ROKIT HEALTHCARE Inc. recently announced that in a second preclinical study using C57BL/6N mice, the hair weight in the candidate substance treatment group increased by 65% under light conditions and 23% under dark conditions compared to the control group. The company explained that it also achieved statistical significance with p-values of 0.01 and 0.03, respectively.
Previously, the company had announced that in its first animal study, the number of active hair follicles increased by 12.8% and hair follicle depth increased by 11.2% at the 4-week mark after administration. In this second study, the company presented new data on hair weight. However, for both studies, no academic journal articles or detailed test reports have been found beyond the company’s announcements.
Specific experimental details—such as the number of animals per treatment group, their sex and age, the exact composition, concentration, route of administration, and frequency of the candidate substance, as well as the treatment protocol for the control group—were not disclosed. It is also unclear how additional evaluation metrics, such as hair follicle stage, hair count, and density, were assessed in the second trial aside from hair weight, making it difficult to independently verify the results.
Since mice have a relatively distinct hair growth cycle, an appropriate hair loss induction model and control group design are necessary to distinguish the effects of the candidate substance from natural regrowth. The interpretation of the data may also vary depending on whether a solvent control group or a positive control group using existing treatments was included, in addition to a simple untreated group.
Critics also point out that the company’s description of the mouse tests as “animal clinical trials” is inaccurate. Animal experiments, which precede human trials, should be referred to as “preclinical.” Experts caution that using the term “clinical” in the context of animal experiments could be misinterpreted as implying a level of validation comparable to human clinical trials, so care must be taken.
The specific meaning of PBM as used by ROKIT HEALTHCARE Inc. is also unclear. PBM generally refers to a form of phototherapy that uses light—such as low-level lasers or light-emitting diodes (LEDs)—to modulate biological responses. A prime example is a helmet-style at-home hair loss treatment device, such as LGELECTRONICS’ “Prael MediHair,” which irradiates the scalp with laser and LED light sources. PBM and low-level laser therapy (LLLT) devices—such as helmets, caps, and combs that emit light onto the scalp—are already commercially available.
A bioindustry official stated, “To differentiate itself from devices typically used for home care, ROKIT HEALTHCARE Inc.’s uniqueness must be demonstrated not by PBM itself, but by the role and functions of naturally derived substances.”
However, the company has not disclosed whether actual light irradiation was conducted in conjunction with the candidate substances it introduced as natural PBM materials; if so, what the wavelength, output, and exposure time were; or whether the candidate substances are light-responsive materials. It is also unclear whether this refers to PBM device therapy in the conventional sense or is the company’s proprietary term for light-responsive materials.
The patent status also needs to be verified. ROKIT HEALTHCARE Inc. announced last January that it had filed a patent application for “natural substance PBM epigenetics” technology and again referred to it as a “patented hair-growth-promoting PBM substance.” However, the company explained in April that the technology was in the preliminary application stage at that time. Currently, no application numbers or other details linked to this candidate substance can be found in patent databases. Since patent applications are typically not made public for 18 months, it remains to be seen whether a formal application has been filed.
Another bioindustry official stated, “While there is significant demand for hair loss treatments that are not hormone-dependent and carry a lower risk of side effects, it is not easy to demonstrate both meaningful efficacy and safety in humans,” adding, “Since it is difficult to judge the reproducibility of the technology or the company’s development capabilities based solely on preclinical data, the company’s dedicated research personnel and clinical development system in the hair loss field must also be verified.”
However, ROKIT HEALTHCARE Inc.’s interim report for this year states that its in-house research institute consists of five dedicated researchers who are engaged in developing protocols and verifying clinical application technologies for organ regeneration—including skin, cartilage, and kidneys—as well as advancing an artificial intelligence (AI)-based organ regeneration platform.
Human trials in India are also subject to verification. The company announced that, starting in the first half of this year, it has been evaluating improvements in hair count, density, and thickness, as well as safety, in 120 participants at four hospitals in Mumbai and Ahmedabad, and plans to release interim analysis results in December.
However, a public search of the Clinical Trials Registry of India (CTRI) revealed no registration record for the 120-participant trial that the company described as a “human clinical trial.” As a general rule, for regulatory clinical trials of pharmaceuticals, the trial must be registered with the CTRI before the first participant is enrolled, and details such as the trial site, principal investigator, ethics committee approval status, sample size, interventions, and outcome measures must be disclosed. Therefore, it is highly likely that this trial is a human application or usability test for cosmetic ingredients or products rather than a clinical trial for drug development.
This is further corroborated by the fact that ROKIT HEALTHCARE Inc. announced in October its plan to pursue registration with the International Nomenclature of Cosmetic Ingredients (INCI) and to first enter certain markets with functional cosmetics or cosmeceutical products. However, INCI is merely a system that assigns international standard names to cosmetic ingredients; it does not imply the ingredient’s hair-growth efficacy, safety, or product marketing authorization in specific countries.
Although the company stated it would pursue a “two-track strategy” of generating initial revenue through functional and cosmeceutical products while simultaneously conducting pharmaceutical clinical trials, the commercialization of cosmetics and the development of pharmaceuticals are separate tracks with different data requirements and regulatory procedures.
A former ROKIT HEALTHCARE Inc. official explained that while it is true the company has long shown interest in the hair loss market, its past business activities were far removed from research on new drug candidates. “In the early 2020s, we tested a medical tourism business connecting Korean customers with hair transplant procedures in Turkey and sold hair loss-related products in the form of dietary supplements,” the official said. “The PBM candidate substance approach announced now appears to be a new approach distinct from those past business ventures.”
Meanwhile, E-Daily attempted to contact ROKIT HEALTHCARE Inc. to inquire about the regulatory nature of the clinical trials in India, whether they were registered with the CTRI, and details regarding the trial sites and ethics review committees, but received no response.
