A Phase 1 interventional study of microbotox and fractional carbon dioxide laser in Skin Abnormalities, sponsored by Assiut University. Not yet recruiting. Open to participants aged 18 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2023-12-27.
Sponsored by Assiut University · Phase 1, Interventional, and Treatment
Skin pores (SP), as they are called by laymen, are common and benign features mostly located on the face (nose, cheeks, etc) that generate many aesthetic concerns or complaints.
Enlarged skin pores refer to conditions that present with visible topographic changes of skin surfaces. Although not a medical concern, enlarged pores are a cosmetic concern for a large number of individuals.
Enlarged facial pores affect individuals of different ages, sexes, and races for which many seek treatment. The exact patho-mechanism of enlarged facial pores is not completely understood. Possible causes include genetic predisposition, seborrhea, aging, increased ultraviolet exposure and comedogenic products.
The treatment of dilated facial pores is difficult, and the ideal modality is not established yet. Many treatment modalities reduce facial pores' count and area, including oral and topical medications as well as different wavelengths of laser. Different ablative and non ablative lasers have been used in the treatment of dilated pores with variable outcomes.
The short-term results showed that treatment with low energy level CO2 fractional laser therapy could be a safe and effective option for patients with Fitzpatrick skin Types III and IV who are concerned with enlarged pores.
Microbotox also called mesobotox, is the injection of multiple microdroplets of diluted onabotulinum toxin A into the upper dermis. It has been previously used in study to decrease pore size and to improve skin texture.
Microbotox has been proved to be effective in improving the sheen and texture of the skin, as well as decreasing sweat and sebum production and enlarged pores as it causes atrophy of sebaceous glands, which subsequently causes tightening of the skin envelope.
39 studies on the registry are indexed under Skin Abnormalities; 7 are open to participants now.
This study's planned enrollment of 21 is below the median of 39 across 26 interventional studies indexed under Skin Abnormalities.
Browse Skin Abnormalities studies →Assiut University is the lead sponsor of 5,078 studies on the registry; 2,178 are open to participants now.
Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side of the face will received single session of microbotox injection contains 20 units of botulinum toxin A.
Drug: microbotox
21 Egyptian patients with wide facial pores will be treated in a split-face manner. In this side will be treated by Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals.
Radiation: fractional carbon dioxide laser
Will be treated by single session of microbotox injection
Also known as: botulinum toxin type A
Two sessions of the fractional CO2 laser on this side of the face at 4-weeks intervals
pore score
evaluation of facial pores after four weeks of second session by pore score: score "0" referred to absence of visible pores. score "1" referred to patients with visible pores. score "2" referred to patient with enlarged pores. score "3" referred to patient with black heads when embedded on facial pores.
Time frame: three months
sebum score
evaluation the degree of seborea after four weeks of second session by sebum score: 0 (dry skin) 1. (mild oiliness) 2. (moderate oiliness) 3. (severe oiliness)
Time frame: three months
Quartile improvement scale
assessment the improvement after four weeks of first session and after four weeks of second session by Quartile improvement scale: 0 = No improvement 1. = Minor/mild improvement (1%-25%) 2. = Moderate improvement (26%-50%) 3. = Marked improvement (51%-75%) 4. = Very significant improvement (76%-100%)
Time frame: three months
Likert satisfaction scale
1. = Very dissatisfied 2. = Dissatisfied 3. = Neither satisfied 4. = Satisfied 5. = Very satisfied
Time frame: three months
No study locations are listed for this record.
Plan to share: No
This study is not yet recruiting, as verified in Dec 2023. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Botulinum toxin type A