An Open Label, Parallel Two Group Clinical Study to Evaluate the Efficacy and Safety of Stretch Mark Oil and Stretch Mark Cream in Prevention and Reduction of Stretch Marks in Pregnant Women and Post- Partum Women
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- Appearance of striae
研究概览
简要总结
Stretch marks (striae) are skin lesions present innumerous physiological and pathological conditions. Based on lesions etiology,many types can be distinguished and the most common ones are striae gravidarum.
Striae gravidarum are common during the firstPregnancy and usually present during the third trimester. Prevalence of Striaegravidarum in women is 43% and usually develops prior to 24 weeks of gestation;however prevalence may ranges from 50 to 90% depending on the population.Striae usually start as reddish and then slightly depressed streaks and fadegradually to leave pale wrinkled lines which will be permanent skin changes.Current research on risk factors, prevention, andmanagement of this condition has been limited or met with little success and/orprovided conflicting results. Considering the unmet need, Himalaya has developedStretch Mark Oil and Stretch Mark Cream with natural ingredients for pregnantwomen and Post- Partum women. It is expected to help to reduce the appearanceand severity of the signs and symptoms associated with stretch marks during andafter the pregnancy without having any harmful effects.
研究设计
- 研究类型
- Interventional
- 分配方式
- Not Applicable
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- Female
入选标准
- •Aged ≥ 18 years at recruitment. Primigravid women. Singleton pregnancy. Women with one of the following: Pregnant women between 12–14 weeks of gestation with absence of abdominal striae (for Group I). Post-Partum women with normal and C-section delivery and visible stretch marks (will be enrolled at the time of discharge- Post-partum.
- •Group-II) Willing to participate and continue with the study follow-ups.
排除标准
- •Multigravida women (due to risk of having striae from an earlier pregnancy) or with already existing striae from earlier weight loss or any other reasons.
- •Women taking corticosteroids for any reason (due to their association with skin striae).
- •High risk pregnancy.
- •Bad obstetric history.
- •Any risk/ infection known to develop congenital anomaly in the baby (TORCH infections).
- •Multiple pregnancies (due to increased maternal weight gain and skin stretching).
- •Women with a known hypersensitivity to agents in formulation (due to risk of allergic reaction).
- •Women with known disorders or illnesses that maybe associated with striae, e.g. Marfan syndrome, Cushing syndrome.
- •Women who decline to discontinue other creams or lotions.
- •Women who are unable to give informed consent.
结局指标
主要结局
Appearance of striae
时间窗: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9.
Visible changes/improvement in the stretch marks, (including the severity, and, color).
时间窗: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9.
Changes /improvement in relief of associated symptoms such as dryness, itching, moisturization and skin texture by using VAS scale
时间窗: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9.
Improvement in skin elasticity and firmness of skin by Elastimeter.
时间窗: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9.
Evaluation for reduction/treatment of stretch marks (including the severity and color) post-delivery the stretch marks
时间窗: visit 1, visit 2, visit 4, and visit 6, at the time of discharge, visit 8 and visit 9.
次要结局
- Prevention of visible appearance of stretch marks during the pregnancy (starting the application from13thweek (± 1 week) of pregnancy).(Relief of associated symptom such as dryness and itchiness during pregnancy and post-partum.)