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.
Przegląd badań
Status
Warunki
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
-
-
Punjab Province
-
Lahore, Punjab Province, Pakistan, 54000
- Lahore General Hospital, Lahore
-
-
Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
- Dziecko
- Dorosły
Akceptuje zdrowych ochotników
Opis
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)
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
|
Eksperymentalny: 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.
|
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.
|
|
Aktywny komparator: 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.
|
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.
|
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Change in Patient and Observer Scar Assessment Scale Score
Ramy czasowe: Baseline and 4, 8, and 12 weeks after initiation of treatment.
|
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.
|
Baseline and 4, 8, and 12 weeks after initiation of treatment.
|
|
Proportion of Participants Achieving Treatment Efficacy
Ramy czasowe: 12 weeks after initiation of treatment.
|
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.
|
12 weeks after initiation of treatment.
|
Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
|
Incidence of Treatment-Related Pain
Ramy czasowe: At 4, 8, and 12 weeks after initiation of treatment.
|
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
|
At 4, 8, and 12 weeks after initiation of treatment.
|
|
Incidence of Treatment-Related Pigmentary Changes
Ramy czasowe: At 4, 8, and 12 weeks after initiation of treatment.
|
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.
|
At 4, 8, and 12 weeks after initiation of treatment.
|
Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Kainat Haq, Lahore General Hospital, Lahore
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów (Rzeczywisty)
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Rzeczywisty)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Inne numery identyfikacyjne badania
- LahoreGeneralH17
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .