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
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