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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| ablative fractional 2940-nm erbium yttrium aluminum garnet (Er: YAG) laser | Experimental |
| |
| non-ablative fractional 1565nm | Experimental |
| |
| 5% minoxidil | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ablative fractional 2940-nm Er: YAG laser | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| TAHC | Use the trichoscopy to assess the changing number of non-vellus hairs in the target area . | week 24 |
| Measure | Description | Time Frame |
|---|---|---|
| HGQA | Hair growth questionnaire assessment | week 8, week 12, week 16, week 24, week 36 |
| TAHC | Use the trichoscopy to assess the changing number of non-vellus hairs in the target area |
| Measure | Description | Time Frame |
|---|---|---|
| Incidents of adverse events | Safety assessment | through study completion, an average of 36 weeks |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Ru Dai | Contact | +8615982215914 | dairu@zju.edu.cn | |
| Ru Dai, M.D | Contact | +8615982215914 | dairu@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Xianjie Wu, Ph.D | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University, China | Recruiting | Hangzhou | Zhejiang | 310009 | China |
The data that support the findings of this study are not publicly available due to the privacy of research participants but are available from the sponsor upon reasonable request.
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| non-ablative fractional 1565nm | Device | Non-ablative fractional 1565nm (Lumenis, M22): Resur Fx len, energy of 30-35J/cm2, density of 200spot/cm2, overlap ≤10%. |
|
| 5% Minoxidil | Drug | topical 5% minoxidil, 1 ml, twice daily |
|
| week 8, week 12, week 20, week 36 |
| TAHW | Use the trichoscopy to assess the changing diameter of non-vellus hairs in the target area | week 8, week 12, week 16, week 24, week 36 |
| IGA | 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. | week 8, week 12, week 16, week 24, week 36 |
| Grade of Norwood-Hamilton | The Grade of Norwood-Hamilton Classification | week 12, week 24, week 36 |
| SSA | 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. | week 8, week 12, week 16, week 24, week 36 |
| ID | Term |
|---|---|
| D000505 | Alopecia |
| ID | Term |
|---|---|
| D007039 | Hypotrichosis |
| D006201 | Hair Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| D053844 | Lasers, Solid-State |
| D008914 | Minoxidil |
| ID | Term |
|---|---|
| D007834 | Lasers |
| D055096 | Optical Devices |
| D004864 | Equipment and Supplies |
| D055618 | Radiation Equipment and Supplies |
| D010880 | Piperidines |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011743 | Pyrimidines |
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