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- Klinische proef NCT07752186
Comparison of Efficacy of Carbon Dioxide Laser With Subcision Versus Platelet-Rich Plasma Bio-Fillers With Subcision for the Treatment of Atrophic Acne
This randomized controlled trial compared two combined treatment approaches for atrophic acne scars. A total of 100 patients aged 15-45 years were enrolled from the Department of Dermatology, Lahore General Hospital, Lahore, and were randomly assigned to one of two treatment groups. All participants underwent subcision, a minor procedure in which fibrous bands beneath depressed acne scars were released to elevate the scarred skin.
Participants in one group received platelet-rich plasma bio-filler injections after subcision. The bio-filler was prepared from each participant's own blood and was injected beneath the acne scars to provide volume and promote collagen formation. Participants in the other group received fractional carbon dioxide laser treatment after subcision. The laser created controlled microscopic skin injuries intended to stimulate collagen production and improve skin texture. Three treatment sessions were administered at 4-week intervals.
Treatment outcomes were assessed using the Patient and Observer Scar Assessment Scale at baseline and during follow-up. Treatment-related adverse effects, including pain, erythema, bruising, and changes in skin pigmentation, were also recorded. Treatment efficacy was defined as a reduction of more than 50% in acne scar severity.
Studie Overzicht
Toestand
Conditie
Studietype
Inschrijving (Werkelijk)
Fase
- Niet toepasbaar
Contacten en locaties
Studie Locaties
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Punjab Province
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Lahore, Punjab Province, Pakistan, 54000
- Lahore General Hospital, Lahore
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
- Kind
- Volwassen
Accepteert gezonde vrijwilligers
Beschrijving
Inclusion Criteria:
- Patients of age 15-45 years,
- both genders,
- presenting with atrophic acne scars
Exclusion Criteria:
- Patients with photosensitive dermatosis, keloids, active acne, already taking steroidal, laser or trial treatment in last 6 months, hepatitis B or hepatitis C, hypothyroidism (TSH>5IU), pregnant or breast feeding, skin infection or inflammatory skin disorders requiring systemic antimicrobials (on medical record).
- Patients with connective tissue disorders or hypersensitivity to lidocaine, taking antiplatelet therapy, bleeding tendencies (on clinical examination)
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Enkel
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: Platelet-Rich Plasma Bio-Filler With Subcision
Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements.
After subcision, 0.1 mL of autologous plasma bio-filler was injected intradermally beneath each marked atrophic acne scar.
Three treatment sessions were administered at 4-week intervals.
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Autologous plasma bio-filler was prepared from 20 mL of venous blood.
The blood was centrifuged at 1,500 revolutions per minute for 10 minutes, followed by a second centrifugation at 3,000 revolutions per minute for 10 minutes.
Approximately 4-5 mL of the upper plasma layer was collected, heated at 80-100°C for 5 minutes, and subsequently cooled at 0-6°C for 5 minutes to produce a viscous bio-filler.
Following subcision, 0.1 mL of the bio-filler was injected beneath each marked scar.
Three treatment sessions were provided at 4-week intervals.
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Actieve vergelijker: Fractional Carbon Dioxide Laser With Subcision
Participants received subcision using an 18-gauge cannula with forward-backward and fanning movements.
Subcision was followed by a single pass of fractional carbon dioxide laser treatment.
Three treatment sessions were administered at 4-week intervals.
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After subcision, the treatment area received a single pass of fractional carbon dioxide laser using a pulse energy of 25 mJ, spot density of 144 spots/cm², pulse interval of 0.5 mm, and pulse duration of 0.1 milliseconds.
Three treatment sessions were provided at 4-week intervals.
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Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Change in Patient and Observer Scar Assessment Scale Score
Tijdsspanne: Baseline and 4, 8, and 12 weeks after initiation of treatment.
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Atrophic acne scar severity was assessed using the Patient and Observer Scar Assessment Scale.
The scale was completed at baseline and at each follow-up assessment.
The change in score from baseline was calculated for each participant and compared between the two treatment groups.
A greater reduction from the baseline score represented greater improvement in acne scar severity.
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Baseline and 4, 8, and 12 weeks after initiation of treatment.
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Proportion of Participants Achieving Treatment Efficacy
Tijdsspanne: 12 weeks after initiation of treatment.
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Treatment efficacy was defined as a reduction of more than 50% in atrophic acne scar severity compared with baseline.
The reduction was determined using the Patient and Observer Scar Assessment Scale.
The number and percentage of participants achieving treatment efficacy were calculated for each treatment group.
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12 weeks after initiation of treatment.
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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
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Incidence of Treatment-Related Pain
Tijdsspanne: At 4, 8, and 12 weeks after initiation of treatment.
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Treatment-related pain was assessed at each follow-up visit and recorded as present or absent.
The number and percentage of participants experiencing pain were compared between the two treatment groups
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At 4, 8, and 12 weeks after initiation of treatment.
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Incidence of Treatment-Related Pigmentary Changes
Tijdsspanne: At 4, 8, and 12 weeks after initiation of treatment.
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Hypopigmentation or hyperpigmentation occurring in the treated area was assessed by clinical examination and recorded as present or absent.
The number and percentage of participants developing pigmentary changes were calculated for each treatment group.
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At 4, 8, and 12 weeks after initiation of treatment.
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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Hoofdonderzoeker: Kainat Haq, Lahore General Hospital, Lahore
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Werkelijk)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Trefwoorden
Andere studie-ID-nummers
- LahoreGeneralH17
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
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