A study to check effectiveness of Adapalene and Benzoyl peroxide Gel in patients with Acne Vulgaris

Completed

• Conditions: Acne vulgaris,

• Registration Number: CTRI/2019/01/017297
• Lead Sponsor: Morningside Healthcare Ltd

Brief Summary

A Randomized,Double-blind, Multicentric, Parallel-group, Active and Placebo Controlled,Three Arm Clinical Study to Compare the Efficacy and Safety of Adapalene 0.1%and Benzoyl peroxide 2.5% Gel (Morningside Healthcare Ltd, UK) versusEPIDUO 0.1%/2.5% Gel (Galderma U.K Ltd) in Subjects with Acne Vulgaris.

550 subjectswill be required to be enrolled (randomized) in the study for around 105 daysthat includes screening periods of 14 days and treatment period of 12 weeks.

The end of the study will be the date of the laststudy visit for the last subject in the study. The study will commence onlyafter the approval from the Local Regulatory Approval (DCGI).

Detailed Description

Not available

Study Timeline

• Study Start: 2019-04-02
• Study Completion: 2019-04-11
• Last Update Posted: 2020-10-01

Recruitment & Eligibility

• Status: Completed
• Sex: All
• Target Recruitment: 550

Inclusion Criteria

• Healthy male or non-pregnant female aged ≥ 09 and ≤ 40 years with a clinical diagnosis of Acne vulgaris with facial involvement.
• A minimum of 20 but not more than 50 inflammatory lesions (papules and pustules) on the face and not more than two acne nodules.
• A minimum of 30 but not more than 100 non-inflammatory lesions (open comedones and closed comedones) on the face.
• 4 Investigator’s Global Assessment (IGA) of acne severity grade 3 OR 4 (refer Table 5) 5.
• Willing to refrain from use of all other topical acne medications or antibiotics during the 12 weeks treatment period.
• Male subjects and female of childbearing potential, willing to use an acceptable form of birth control including abstinence, from study start to 30 days after the last application of study medication.
• Have used the same brand of make-up for a minimum period of 2 weeks prior to randomization, for subjects who use make-up, and agree to not change make-up brands or types during the study.
• Willingness and ability to comply with the protocol (for subjects under 18 years of age, the parent/LAR must also have been willing and able to comply with study requirements).
• Willing to provide written informed consent or assent (as applicable).

Exclusion Criteria

• Females who are breast feeding, pregnant or planning to become pregnant.
• Any acne cyst.
• Presence of any skin condition that would interfere with the diagnosis or assessment of acne vulgaris (e.g., on the face: rosacea, dermatitis, psoriasis, squamous cell carcinoma, eczema, acneform eruptions caused by medications, steroid acne, steroid folliculitis, or bacterial folliculitis).
• Subjects who have acne conglobata, acne fulminans, nodulocystic acne and secondary acne (e.g., chloracne and drug induced acne).
• Excessive facial hair (e.g. beards, sideburns, moustaches, etc.), tattoos that would interfere with diagnosis or assessment of acne vulgaris.
• Well-trimmed moustaches are allowed.
• Subjects who have performed wax epilation of the face within 14 days prior to baseline.
• History of hypersensitivity or allergy to adapalene, benzoyl peroxide, retinoids and/or any of the study medication ingredients 8.
• Subjects who have a severe or intense irritation on the Face.
• Use within 6 months prior to baseline (Randomization) or during the study of oral retinoids (e.g. Accutane®) or therapeutic vitamin A supplements of greater than 10,000 units/day (multivitamins are allowed).
• Use for less than 3 months prior to baseline (Randomization) of estrogens or oral contraceptives; use of such therapy is allowed, if it will remain constant throughout the study.
• Use on the face within 1 month prior to baseline (Randomization) or during the study of: 1) cryodestruction or chemodestruction, 2) dermabrasion, 3) photodynamic therapy, 4) acne surgery, 5) intralesional steroids, or 6) x-ray therapy, or 7) chemical or laser peel.
• Use within 1 month prior to baseline (Randomization) of: 1) androgen receptor blockers for acne (such as spironolactone or flutamide), 2) systemic steroids (including intranasal and inhaled corticosteroids), 3) systemic antibiotics, 4) systemic treatment for acne vulgaris (other than oral retinoids, which require a 6-month washout), or 5) systemic anti-inflammatory agents.
• Use within 2 weeks prior to baseline or during the study of 1) topical steroids, 2) topical retinoids, 3) topical acne treatments including over-thecounter preparations, 4) topical anti-inflammatory agents, or 5) topical antibiotics.
• Use of astringents and toners for less than 2 weeks prior to the start of the study.
• Use of abradants, facials, peels containing glycolic or other acids, masks; washes or soaps containing benzoyl peroxide, salicylic acid, or sulfacetamide sodium; non-mild facial cleansers; moisturizers that contained retinol, salicylic acid or α- or β-hydroxy acids within the previous 2 weeks.
• Concomitant use/planned to use of mega-doses of certain vitamins (such as vitamin D [> 2000 IU/day], vitamin B6 [> 2 mg/day] and vitamin B12 [> 1 mg/day]), haloperidol, halogens such as iodide and bromide, lithium, hydantoin and phenobarbital.
• Anti-pruritic, including antihistamines, within 24 hour of baseline visits 18.
• Use of tanning booths or tanning lamps within 1 week prior to baseline and an unwillingness to refrain from use during the study.
• Have any systemic or dermatologic disease that may affect the evaluation of study results.
• Subjects with clinically significant unstable medical disorders, life threatening disease, or current malignancies..
• Current drug abuse (including, but not limited to, cannabinoids and cocaine) or alcohol abuse (greater than two drinks per day).
• Subjects with any local tolerability assessment score 3 (severe, marked/intense).
• Lived in the same household as currently enrolled subjects.
• Subjects who have been treated with an investigational drug or investigational device within a period of 30 days prior to study enrollment.
• Subjects who have been previously enrolled in this study.
• Clinically significant abnormal findings or condition (other than acne vulgaris), which might, in the opinion of the Investigator, interfere with study evaluations or pose a risk to subject safety during the study.

Study & Design

• Study Type: BA/BE
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Mean percent change from baseline to week 12 (Day 84) for inflammatory	At baseline, Week 4, Week 8 and week 12
Mean percent change from baseline to week 12 (Day 84) in the noninflammatory	At baseline, Week 4, Week 8 and week 12
(open and closed comedones) lesion count.	At baseline, Week 4, Week 8 and week 12
(papules and pustules) lesion count.	At baseline, Week 4, Week 8 and week 12

Secondary Outcome Measures

Name	Time	Method
Proportion of subjects with a clinical response of “success†at week 12.	12 week

Trial Locations

Locations (20)

Amena Khatun General Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

B.J. Government Medical College & Sassoon Gen Hospital; 🇮🇳 Pune, MAHARASHTRA, India

Dhiraj General Hospital; 🇮🇳 Vadodara, GUJARAT, India

DHL Research Centre; 🇮🇳 Ahmadabad, GUJARAT, India

Gandhi Hospital; 🇮🇳 Hyderabad, TELANGANA, India

Government Medical College & Hospital; 🇮🇳 Nagpur, MAHARASHTRA, India

Govt. Medical College and SSG Hospital; 🇮🇳 Vadodara, GUJARAT, India

Indira Gandhi Institute of Medical Sciences; 🇮🇳 Patna, BIHAR, India

Institute of medical Sciences; 🇮🇳 Varanasi, UTTAR PRADESH, India

Jivraj Mehta Hospital; 🇮🇳 Ahmadabad, GUJARAT, India

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Amena Khatun General Hospital

🇮🇳Ahmadabad, GUJARAT, India

Dr Ipsa Pandya

Principal investigator

9904704445

niip257@yahoo.in