Health Condition 1: L649- Androgenic alopecia, unspecified
Conditions
Interventions
Intervention1: Elyara Hair Peptides: intradermal scalp injections, approximately 2 mL/session, administered at Day 0, Week 2, Week 4, and Week 6.
Control Intervention1: NA: NA
Sponsors
Medvital Ventures Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: Subjects must fulfill all inclusion criteria to participate in the study: 1.Male and female patients aged eighteen to fifty five years. 2.Clinical diagnosis of androgenetic alopecia. 3.Male pattern hair loss corresponding to Norwood Hamilton Stage Two to Stage Four A. 4.Female pattern hair loss corresponding to Savin Scale Type One to Type Two. 5.Patients with early to moderate stages of hair loss. 6.Stable hair loss pattern for at least six months prior to screening. 7.Willingness to undergo injectable hair filler treatment. 8.Willingness and ability to comply with all study procedures and follow up visits. 9.Ability to provide written informed consent. 10.Agreement to maintain the same hair care routine throughout the study period. 11.Agreement not to initiate any new hair loss treatment during the study period.
Exclusion criteria
Exclusion criteria: 1.Scarring alopecia including lichen planopilaris and frontal fibrosing alopecia. 2.Known hypersensitivity or allergy to any component of Elyara Hair Peptides including hyaluronic acid or peptide complexes. 3.Active scalp infections or inflammatory scalp conditions including bacterial infections, viral infections, fungal infections, psoriasis, or severe seborrheic dermatitis. 4.Severe autoimmune diseases. 5.Subjects receiving medications known to affect hair growth including chemotherapy, retinoids, anticoagulants, or antiepileptic medications. 6.Pregnant or lactating women. 7.Advanced stages of hair loss defined as Norwood Hamilton Stage greater than Stage Four A in males or Savin Scale greater than Type Two in females. 8.History of hair transplantation within the previous twelve months. 9.Recent hair growth treatments within the last three months including platelet rich plasma therapy, mesotherapy, hair filler treatments, or initiation of finasteride or dutasteride therapy. 10.Use of hair weaving, hair extensions, hair relaxers, or occlusive wigs within thirty days prior to screening. 11.Use of topical minoxidil within four weeks prior to baseline. 12.Presence of other hair disorders including alopecia areata. 13.Patients with bleeding disorders or receiving anticoagulant therapy. 14.Uncontrolled systemic illnesses including uncontrolled diabetes mellitus or severe cardiovascular disease. 15.Participation in another clinical trial within the last three months. 16.Subjects with unrealistic expectations or inability to comply with study procedures and follow up requirements.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate the effectiveness of Elyara Hair Peptides in subjects with androgenetic alopecia by assessing the change in hair density from baseline to Week 12 using trichoscopic evaluation.Timepoint: Baseline and Week 12 | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate changes in hair growth parameters including hair count, anagen percentage, telogen percentage, terminal hair percentage, vellus hair percentage, mean hair thickness, and follicular units using trichoscopy, and to assess investigator global improvement, subject satisfaction, and safetyTimepoint: Baseline and Week 12 | — |
Countries
India
Contacts
Public ContactDr B S Chandrashekar
CUTIS Academy of Cutaneous Sciences
Outcome results
None listed