None listed
Conditions
Interventions
Intervention1: Red-light photobiomodulation therapy using a wearable medical device: Participants will use a wearable red-light photobiomodulation (PBM) device delivering non-ionizing red light (appro
Sponsors
Dr Viral Desai
Eligibility
Inclusion criteria
Inclusion criteria: Adults aged 20 to 55 years, male or female. Individuals with self-perceived hair and/or scalp concerns such as increased hair fall, reduced hair density or fullness, altered hair texture, dandruff/flaking, or scalp itching for at least 3 months. Participants not previously diagnosed or treated with prescription-based medical therapy for hair loss or scalp conditions (e.g., no prior dermatologist-prescribed minoxidil, finasteride, anti-androgens) in the preceding 12 months. Willingness to use the red-light therapy device as instructed for the study duration (24 weeks). Willingness to refrain from initiating any new hair or scalp treatments (medical, procedural, or nutraceutical) during the study period. Ability and willingness to provide written informed consent. Ability to comply with study visits and follow-up schedule, including the post-intervention retention visit.
Exclusion criteria
Exclusion criteria: Presence of scarring alopecia or any active inflammatory scalp disorder requiring medical treatment (e.g., psoriasis, severe seborrheic dermatitis). Use of prescription treatments for hair loss (topical or oral), including minoxidil, finasteride, anti-androgens, or similar therapies, within the last 6 months. History of procedural hair treatments such as hair transplantation, platelet-rich plasma (PRP), microneedling, or other scalp procedures within the last 12 months. Known photosensitivity disorders or current use of photosensitizing medications, as assessed by the investigator. Pregnant or breastfeeding women. Presence of uncontrolled systemic illnesses known to affect hair shedding (e.g., uncontrolled thyroid disease, severe anaemia), unless medically stabilized. Active scalp infection, open wounds, or broken skin at the intended application sites. Participation in another interventional clinical study within the last 3 months. Any condition which, in the opinion of the investigator, would interfere with safe participation, compliance, or interpretation of study results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in overall hair and scalp cosmetic quality and wellness, assessed using the HAIR-Q questionnaire scoreTimepoint: At Baseline, Week 6, Week 12, Week 24, and Month 12 (retention) | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in scalp flaking severity using the Adherent Scalp Flaking Score (ASFS). Change in hair shedding assessed by the Standardized 60-Second Hair Comb Test. Change in scalp itch severity assessed by the 5-D Itch Scale (or Itch NRS). Change in dermatology-related quality of life assessed by DLQI. Investigator-rated global improvement in hair appearance using standardized photographic assessment. Change in objective hair parameters (hair density and shaft diameter) assessed by trichoscopy, where feasible. Maintenance of treatment effect assessed at 12-month post-intervention follow-up.Timepoint: At Baseline, Week 6, Week 12, Week 24, and Month 12 (retention) | — |
Countries
India
Contacts
Public ContactDr Viral Desai
Sarla Hospital and ICU
Outcome results
None listed