Microneedling With Topical Glycolic Acid 35% Versus Microneedling With Topical Insulin in the Treatment of Atrophic Post-acne Scars
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 主要终点
- Quartile grading system
研究概览
简要总结
To examine the anti-scarring effect of topical glycolic acid 35% combined with microneedling against that of topical insulin combined with microneedling for post acne scars
详细描述
Acne vulgaris (AV) is a common chronic inflammatory disease of skin that develops from sebaceous glands associated with hair follicles. Typically AV begins at puberty and may continue through adulthood affecting the comedogenic areas of face, back and chest .
One of the undesirable outcomes of acne is acne scars that are divided into two main types based on a loss (atrophic) or gain (hypertrophic) of collagen. Atrophic type is the most common type, further subdivided into three subtypes: icepick, boxcar and rolling scar .
Post acne scars occur in nearly 75% of patients with acne affecting both male and female equally . Acne scars impair quality of life and may be a risk factor for depression, suicide, low academic performance and unemployment .
There are different therapeutic modalities for atrophic acne scars including microneedling, chemical peeling, laser, filler, surgical procedures (punch excision, punch grafts) and fat transfer.
Microneedling is considered safe for all skin types. It is performed by dermapen or dermaroller to induce new collagen formation that remains for a few months after the procedure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •All types of facial atrophic acne scars
- •Patients aged >18 years
- •Both sexes
排除标准
- •Pregnancy and lactation
- •Active acne or any active facial lesion
- •History of keloid scar
- •History of systemic diseases as DM or hypotension
- •Bleeding and coagulation disorders
- •Infection and immunosuppression
研究组 & 干预措施
Glycolic acid 35% group
will be subjected to microneedling with topical glycolic acid 35%.
干预措施: microneedling with topical glycolic acid 35%. (Drug)
topical insulin group
will be subjected to microneedling with topical human insulin solution.
干预措施: microneedling with topical human insulin solution. (Drug)
结局指标
主要结局
Quartile grading system
时间窗: through study completion, an average of 1 year
The improvement of patients is evaluated as follow: Poor (improvement \< 25%) Mild (improvement 26%-50%) Good (improvement 51%-75%) Excellent (improvement \>75%)
Goodman and Baron's acne scar grading system
时间窗: through study completion, an average of 1 year
Grade 1 Erythematous hypo or hyperpigmented flat marks Grade 2 Mild atrophy not obvious at social distance of \>/=50 cm or easily covered by makeup or beard hair in male Grade 3 Moderate atrophy obvious at social distance of \>/=50 cm, not easily covered by makeup or beard hair but able to be flattened by manual stretching of the skin Grade 4 Sever atrophy obvious at social distance \>50 cm, not easily covered by makeup and not able to be flattened by manual stretching of skin
5 point scale for evaluating patient's satisfaction
时间窗: through study completion, an average of 1 year
None (no satisfaction) Mild (1%-25% satisfaction) Moderate (26%-50% satisfaction) Good (51%-75% satisfaction) Very good (76%-100% satisfaction)
Pain assessment
时间窗: through study completion, an average of 1 year
Pain during the session will be assessed and graded as mild, moderat and sever (Saadawi et al., 2018).
次要结局
未报告次要终点
研究者
Norhan Anees
Principal Investigator
Zagazig University