跳至主要内容
临床试验/CTRI/2009/091/001073
CTRI/2009/091/001073招募中4 期

TO EVALUATE THE EFFICACY AND SAFETY OF FIXED DOSE 1.5 % AMINEXIL AND 5 % MINOXIDIL TOPICAL SOLUTION V/S 5 % MINOXIDIL TOPICAL SOLUTION IN MALE PATTERN HAIR LOSS.

Glenmark Pharmaceuticals Ltd0 个研究点目标入组 204 人开始时间: 待定最近更新:

试验速览

阶段
4 期
状态
招募中
发起方
入组人数
204

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional

入排标准

入选标准

  • 1. Male patients of age between 18 to 50.
  • 2. Presence of androgenetic alopecia based on the Norwood Hamilton Scale grade 3 and 4 with
  • vertex involvement (Appendix B).
  • 3. Accepting not to use products with the same end benefit during the entire study duration.
  • 4. For whom the Investigator considers that the compliance will be correct.
  • 5. Cooperating, informed of the need and duration of the examinations, and ready to comply with
  • protocol procedures.
  • 6. Having signed a Consent Form and will be once informed orally and in writing of all information
  • concerning the study procedures and study objectives.

排除标准

  • 1. Alopecia areata, alopecia totalis, alopecia universalis and alopecia diffusa.
  • 2. Scarring of the scalp or any other condition or disease of the scalp or hair, including diseases of
  • the hair shaft and inability to discontinue use of hair weaving.
  • 3. Volunteers with any cardiac abnormalities or ailments or abnormal blood pressure.
  • 4. Use of the following during the 6 months prior to screening:
  • ? Minoxidil (oral or topical)
  • ? Drugs with anti-androgenic properties (e.g., cyproterone acetate, spironolactone,
  • ketoconazole, flutamide, bicalutamide). Cimetidine cannot be used during the study but is not
  • an excluded drug when used during the previous 6 months.
  • ? Drugs potentially causing hypertrichosis (e.g., cyclosporine, diazoxide, phenytoin psoralens)
  • ? Anabolic steroids
  • ? Lithium and phenothiazines.
  • 5. Use of systemic steroids for more than 14 days within the past 2 months prior to enrollment in
  • 6. Use of isotretinoin, radiation to the scalp, or chemotherapy within the past year.
  • 7. Known sensitivity to the investigational product.
  • 8. Hypersensitivity to any cosmetic product, raw material.
  • 9. Any clinically significant systemic or cutaneous disease, which may interfere with study
  • treatments or procedures.
  • 10. Subjects on any medical treatment either systemic or topical which may interfere with the
  • performance of the study treatment (presently or in the past 1 month).
  • 11. Subject in an exclusion period or participating in another similar cosmetic or therapeutic trial.

研究者

发起方
Glenmark Pharmaceuticals Ltd

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