Comparison of Topical Clascoterone and Adapalene for Mild Acne Vulgaris
Comparison of Efficacy of Topical Clascoterone With Topical Adapalene in the Treatment of Mild Acne Vulgaris
There is no local data available regarding the comparative efficacy of topical clascoterone and topical adapalene, particularly in patients with mild acne vulgaris. The findings of this study will help dermatologists identify the more effective topical treatment for mild acne vulgaris, leading to improved patient outcomes and better utilization of healthcare resources. Furthermore, the study will contribute local data to the existing literature and may assist in developing evidence-based treatment recommendations for patients with mild acne vulgaris in our setting.
Patients meeting the inclusion criteria from the Dermatology Unit, Khyber Teaching Hospital, MTI, Peshawar will be incorporated into the study following approval from the ethics committee. At the commencement of the trial, baseline demographics including gender, age, height, weight, BMI, duration of acne, socioeconomic status, profession, monthly income, education level and residential status will be documented. An elaborate explanation of the process involved in the study will be provided to the participants, and consent will be taken following an explanation of the pros and cons involved.
Randomization will be performed by computer generated random list. The group assignments will be put into sealed envelopes, which will be opened when the patient will be included in study. 30 patients will be in topical clascoterone group (A) while 30 patients will be in topical adapalene group (B).
Patients allocated to Group A will receive topical clascoterone 1% cream. It is required that they will clean their faces using a mild cleansing agent, dry their faces and thereafter apply a thin coating of clascoterone 1% cream to their whole face area in the morning and evening for 12 consecutive weeks.
Patients allocated to Group B will receive topical adapalene 0.1% gel. Patients will cleanse the skin using a gentle cleanser, allow it to dry in the air for 10 minutes, and then apply one pea-sized amount of 0.1% adapalene gel over their entire affected area of the face once a day before going to bed for 12 weeks.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Geschätzt)
Phase
- Frühphase 1
Kontakte und Standorte
Studienkontakt
- Name: Haider Ali, MBBS,CHR
- Telefonnummer: +923018078258
- E-Mail: drhaider1001@gmail.com
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
- Kind
- Erwachsene
Akzeptiert gesunde Freiwillige
Beschreibung
Inclusion Criteria:
- Clinical diagnosis of mild acne vulgaris as per operational definition
- Male or female patients
- Age 12 to 35 years
Exclusion Criteria:
- History of acne conglobata
- History of acne fulminans
- Use of topical anti-acne medications within the last 4 weeks
- Use of systemic anti-acne therapy within the last 12 weeks
- Known hypersensitivity or allergy to clascoterone or adapalene
- History of eczema
- History of rosacea
- History of seborrheic dermatitis
- History of psoriasis
- Presence of active skin infections
- Pregnant women
- Lactating women
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Einzelgruppenzuweisung
- Maskierung: Keine (Offenes Etikett)
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
|---|---|
|
Experimental: topical CLASCOTERONE 1 percent cream
|
Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.
Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.
|
|
Aktiver Komparator: Topical adapalene 0.1 percent gel
|
Participants in this group will apply topical clascoterone 1% cream to the affected areas as prescribed for the duration of the study.
Participants in this group will apply topical adapalene 0.1% gel to the affected areas as prescribed for the duration of the study.
|
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
|---|---|---|
|
IGA achievement
Zeitfenster: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
|
investigator global assessment achievement of 0 which is clear face or 1 which is almost clear
|
Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
|
|
Achievement of and IGA score of 0(clear) or 1(almost clear) after 12 weeks of treatment
Zeitfenster: Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
|
Investigator global assessment scoring
|
Baseline to 12 Weeks Participants will be assessed at baseline and at 12 weeks following initiation of treatment. Efficacy will be determined by the change in acne lesion counts and clinical improvement from baseline to week 12.
|
Mitarbeiter und Ermittler
Sponsor
Publikationen und hilfreiche Links
Allgemeine Veröffentlichungen
- Morshed ASM, Noor T, Uddin Ahmed MA, Mili FS, Ikram S, Rahman M, Ahmed S, Uddin MB. Understanding the impact of acne vulgaris and associated psychological distress on self-esteem and quality of life via regression modeling with CADI, DLQI, and WHOQoL. Sci Rep. 2023 Nov 30;13(1):21084. doi: 10.1038/s41598-023-48182-6.
- Vasam M, Korutla S, Bohara RA. Acne vulgaris: A review of the pathophysiology, treatment, and recent nanotechnology based advances. Biochem Biophys Rep. 2023 Nov 23;36:101578. doi: 10.1016/j.bbrep.2023.101578. eCollection 2023 Dec.
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn (Geschätzt)
Primärer Abschluss (Geschätzt)
Studienabschluss (Geschätzt)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Tatsächlich)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Tatsächlich)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- 383/IREB/KTH
Plan für individuelle Teilnehmerdaten (IPD)
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