跳至主要内容
临床试验/CTRI/2024/08/072306
CTRI/2024/08/072306尚未招募2 期

A full face, baseline controlled study to evaluate the efficacy of Dermapen 4™ microneedling device in conjunction with MG-CLR serum for acne treatment over 12 weeks. - NI

Equipmed USA LLC0 个研究点目标入组 0 人开始时间: 待定最近更新:

试验速览

阶段
2 期
状态
尚未招募
发起方

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

  • Female subjects aged between 18-45 years (both ages inclusive).
  • Fitzpatrick skin phototype I to VI.
  • Subjects having IGA score of 2 and 3.
  • Subjects who have not received any kind of treatment for acne 1 month before the start of the study.
  • Subject free of excessive hair, cuts, abrasions, fissures, wounds, lacerations, or any other skin conditions on the face.
  • Subjects who agree not to use any other product/treatment/home remedy/except the provided products on their face during the study period.
  • Subjects who agree not to carry out bleaching or any other procedures including facial etc. on face during the study period.
  • Subjects who agree not to expose to excessive sunlight. (Sun exposure not more than two hours daily and during that time use of an umbrella to cover the face).
  • Subjects willing to give a voluntary written informed consent, photography release, and agree to come for regular follow-up.
  • Subjects willing to abide by and comply with the study protocol.

排除标准

  • 1.Subjects with known skin condition that may impact the assessment.
  • 2.Subjects with active Herpes labialis infection.
  • 3.Subjects known to have bleeding and clotting disorders (self-declared).
  • 4.Subjects known to have connective tissue disorders.
  • 5.Subjects with any other signs of significant local irritation or skin disease.
  • 6.Subjects currently taking any medication, which the investigator believes may influence the interpretation of the data.
  • 7.Subjects having clinically significant systemic or cutaneous disease, chronic illness or major surgery in the last year.
  • 8.Subjects undergoing treatment of any skin condition on their face.
  • 9.Subjects not willing to discontinue other topical facial products.
  • 10.Subjects who are allergic or sensitive to bar cleansing products, cosmetics, creams/lotions, artificial jewelry or anything else.
  • 11.Subjects who have participated in a similar clinical study 4 weeks before this study.
  • 12.Subjects who are pregnant or nursing (self-declared).
  • 13.Subjects with skin allergy history or atopic dermatitis or psoriasis.
  • 14.Subjects who are on any kind of supplements or taking nutraceuticals.
  • 15.Subject who are on any medication like blood thinners, excessive hormonal acne, cystic acne.
  • 16.Subject is an employee of the sponsor or the CRO.

研究者

发起方
Equipmed USA LLC

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