Background: 5-aminolevulinic acid (5-ALA) stimulates murine hair growth in vivo study. Glycyl- Histidyl-Lysine (GHK) peptide increases hair follicle size and stimulates stem cell proliferation. Objectives: To investigate the efficacy of a combination of 5-ALA and GHK peptide (ALAVAX) on hair growth Methods: Cell culture of keratinocyte, melanocytes and fibroblast was performed for MTT assay. Seven-week old C57BL/6N mice were treated with 100 mg/ml ALA ± 5-minute red or blue LED or 100 mg/ml ALAVAX ± 5-minute red or blue LED once a day for 24 days for evaluation of hair growth. Cultured human hair organs were treated with 100 times-diluted ALAVAX ± 20-minute red LED for 7 days. Forty five patients with male pattern hair loss were treated with ALAVAX once a day for 6 months. Total hair count, hair diameter, hair length and patients’ assessment were evaluated at week 4, 12 and 24 after treatment. The penetration of ALAVAX into hair follicles was examined under the fluorescent microscopy. Results: Hair growth was most conspicuous in mice treated with ALAVAX + red LED. Hair growth of cultured hair organs was significantly increased after treatment with ALAVAX only. Total hair count, hairlength and patients’ assessment in humans was significantly improved in the group treated with ALAVAX. No adverse event was reported. The penetration of ALAVAX in human hair follicles was prominent. Conclusion: ALAVAX could be considered as one of the useful agents for the treatment of male pattern hair loss.