Dr. Arslan Musbeh, MD
Hair Restoration Surgeon
Founder – Hairmedico
Lecturer, Claude Bernard University Lyon 1
17+ Years of Experience in FUE, Sapphire FUE, and DHI Hair Transplantation
Clascoterone (Breezula®) is a topical androgen receptor antagonist developed for the management of androgenetic alopecia (AGA). As patient demand shifts toward non-systemic hair loss therapies, clascoterone has emerged as a promising option for localized androgen modulation. However, its clinical role is frequently misunderstood and overstated.
This clinical white paper provides a comprehensive evaluation of clascoterone’s pharmacological mechanism, clinical limitations, evidence base, patient selection criteria, and integration into surgical and non-surgical hair restoration strategies, including post–hair transplant use.
Core conclusion: Clascoterone does not induce new hair follicle formation. Its therapeutic value lies in slowing disease progression and preserving existing hair follicles, particularly as part of long-term maintenance protocols.
Androgenetic alopecia is the most common form of hair loss worldwide, affecting up to 80% of men and 50% of women during their lifetime. Although medically benign, AGA has a significant psychological and social impact, driving sustained demand for effective and safe treatments.
While oral 5α-reductase inhibitors remain effective, concerns regarding systemic exposure and side effects have accelerated interest in topical, localized anti-androgen therapies, positioning clascoterone at the forefront of current research.
AGA is driven by genetically determined follicular sensitivity to androgens, primarily dihydrotestosterone (DHT).
Conversion of testosterone to DHT via 5α-reductase
Binding of DHT to androgen receptors in dermal papilla cells
Progressive follicular miniaturization
Shortening of the anagen (growth) phase
Transition from terminal to vellus hair
Eventual follicular dormancy
Once follicular stem cell niches are irreversibly damaged, pharmacologic regeneration is not possible.
Unlike therapies that reduce systemic androgen levels, clascoterone targets the final common pathway of androgen action by competitively blocking androgen receptors at the follicular level.
This strategy aims to:
Reduce local androgen signaling
Slow follicular miniaturization
Preserve follicular integrity
Avoid systemic hormonal suppression
Clascoterone (CB-03-01) is a non-steroidal anti-androgen formulated for topical dermatologic use.
Competitive inhibition of androgen receptors
Localized scalp activity
Rapid metabolism into inactive compounds
Minimal systemic hormonal impact
Low systemic absorption
No clinically meaningful serum androgen suppression
Favorable profile for long-term use
FDA-approved for acne vulgaris
Demonstrates validated local anti-androgen activity
Hair loss use remains off-label
Developed specifically for androgenetic alopecia
Investigated in Phase II and III clinical trials
Optimized for scalp penetration and follicular receptor inhibition
Available clinical data indicates:
Modest increases in target area hair count
Slower progression compared to placebo
Improved hair cycle stability
Critically, no clinical trial demonstrates new hair follicle formation. Observed improvements reflect preservation of existing follicles and delayed miniaturization, not regeneration.
Hair follicles are embryologically determined structures. Once destroyed, they cannot be recreated pharmacologically.
❌ Hair regrowth drug
❌ Replacement for finasteride in all cases
❌ Alternative to hair transplantation
✔ Disease-modifying
✔ Progression-slowing
✔ Maintenance-focused therapy
Early to moderate AGA
Diffuse thinning with residual follicles
Patients avoiding systemic anti-androgens
Post–hair transplant patients for native hair preservation
Advanced baldness with slick scalp
Patients expecting density restoration without surgery
Hair transplantation remains the only definitive method for restoring hair in areas of permanent follicular loss.
Stabilizes ongoing hair loss
Protects native hair adjacent to recipient zones
From a surgical and clinical perspective, we consider clascoterone to be potentially effective in the post–hair transplant period, particularly for preserving native, non-transplanted hair.
Hair transplantation restores follicles in bald areas but does not halt the underlying androgenetic process affecting remaining hair. Progressive miniaturization of native follicles may continue if androgen activity is not managed.
Based on its mechanism of action, postoperative use of clascoterone may contribute to:
Reduced androgen receptor activation in native follicles
Slower miniaturization of non-transplanted hair
Improved long-term balance between transplanted and existing hair
Better maintenance of overall scalp density harmony
It is important to note that clascoterone does not affect the survival or growth of transplanted grafts themselves. Its value lies in protecting surrounding native hair, which is essential for long-term aesthetic stability.
In postoperative protocols, clascoterone should be positioned as:
A supportive maintenance therapy
Part of long-term medical management of AGA
A strategy to reduce future contrast between transplanted and non-transplanted zones
This role is preventive, not regenerative, and complementary to surgery.
Optimal outcomes are achieved through a multimodal approach, which may include:
Topical or oral minoxidil
PRP therapy
Medical-grade scalp care
Nutritional and lifestyle optimization
Such layered strategies reflect best practice in modern hair restoration.
Clascoterone’s localized action offers:
High patient compliance
Low discontinuation rates
Minimal systemic side effects
This makes it particularly suitable for long-term disease management.
Breezula® is developed by Cosmo Pharmaceuticals N.V., a research-driven dermatology-focused pharmaceutical company. The product represents a strategic extension of Cosmo’s clascoterone platform, following the FDA approval of clascoterone 1% (Winlevi®).
Importantly, Cosmo positions Breezula® as a maintenance and disease-modifying therapy, not a follicular regeneration drug—fully aligned with current scientific consensus.
Accurate positioning is essential to maintain patient trust. Overstating efficacy leads to unrealistic expectations and dissatisfaction.
Clascoterone must be communicated as:
Supportive
Preventive
Maintenance-focused
Not curative.
Clascoterone (Breezula®) represents a meaningful advancement in localized androgen modulation for androgenetic alopecia. While it does not regenerate hair follicles, it plays a valuable role in slowing disease progression, preserving existing hair, and supporting long-term outcomes, particularly after hair transplantation.
Used appropriately, it enhances both medical and surgical hair restoration strategies.
Dermatology Times; Cosmo Pharmaceuticals Pipeline; American Hair Loss Association; Perfect Hair Health; The Derm Digest.
This clinical white paper has been approved by Dr. Arslan Musbeh.
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