Androgenetic Alopecia
Conditions
Brief summary
Laser sources have established their potential effect in inducing hair regrowth. No study has compared the effect of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA).
Detailed description
The investigators performed a prospective study between to compare the efficacy and safety of ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser and non-fractional 15650nm fractional laser in the treatment of androgenetic alopecia (AGA). The efficacy of the two therapies was evaluated by the investigator's Global Assessment (IGA) scores and the patient's Likert satisfaction scale at week 12 and week 24. Changes in total, terminal and villous hair count, total and terminal hair diameter, and AGA grade were also recorded. Adverse events were evaluated at each follow-up.
Interventions
DEVICEablative fractional 2940-nm Er: YAG laser
Ablative fractional 2940-nm Er: YAG laser (Dermablate MCL31, Asclepion Laser Technologies, Germany), the following parameters were used: model of N25%, energy density of 20-30J/cm2, pulse time of 300μs and one to two passes.
DEVICEnon-ablative fractional 1565nm
Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%.
DRUG5% Minoxidil
topical 5% minoxidil, 1 ml, twice daily
Sponsors
Second Affiliated Hospital, School of Medicine, Zhejiang University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
MALE
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* age between 18 and 65 years;； * clinical diagnosis of AGA； * AGA diagnosis was evaluated following Norwood Hamilton grade II-V criteria； * no previous laser treatments for AGA in the past six months before enrollment； * willingness to provide pictures and follow-up studies.
Exclusion criteria
* if presented with severe diseases of internal organs, eyes, or skin; * inflammation, infection, or unhealed wounds on the skin around the site of treatment on the head; * systematic treatment with corticosteroids or other immunosuppressants and immunomodulators in the past 3 months
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| TAHC | week 24 | Use the trichoscopy to assess the changing number of non-vellus hairs in the target area . |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| HGQA | week 8, week 12, week 16, week 24, week 36 | Hair growth questionnaire assessment |
| TAHC | week 8, week 12, week 20, week 36 | Use the trichoscopy to assess the changing number of non-vellus hairs in the target area |
| TAHW | week 8, week 12, week 16, week 24, week 36 | Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area |
| Grade of Norwood-Hamilton | week 12, week 24, week 36 | The Grade of Norwood-Hamilton Classification |
| SSA | week 8, week 12, week 16, week 24, week 36 | Subject self-assessment. SSA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair. |
| IGA | week 8, week 12, week 16, week 24, week 36 | Investigator's Global Assessment. IGA was evaluated using a 7-point scale as follows: -3= obvious reduction of hair; -2= moderate reduction of hair; -1= mild reduction of hair; 0= change; 1= mild growth of hair; 2= moderate growth of hair; 3= obvious growth of hair. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Incidents of adverse events | through study completion, an average of 36 weeks | Safety assessment |
Countries
China
Contacts
Primary ContactRu Dai
Backup ContactRu Dai, M.D
Outcome results
None listed